Catalogue Gants & Masques
Catalogue Fevrier 202 2
1
Sommaire
o Gants …………………… .. ……………………………………………………… . ……… . p07 ▪ Nitriles - Import Asie .. ……………………… . … .. …………… p08 ▪ Latex & Vinyl . … . ……………… .. …………… . ……………… p13 o Masques Jetables . ………… . …… . ……………………………………………… . p14 ▪ 3 plis chirurgicaux • Type I …………………………… . …………… . ………… . p15 • Type II .. ………………………… .. ……… . ………………………… . p25 • Type IIR .. ………… .. ………………… . ………………… . p28 ▪ FFP2 • KN95 ………………………………………………… .. … .. ……………… .. p37 • FFP2 sans valve …… .. ……………………… . ……… .. ……… ... p43 • FFP2 avec valve . …………………………… ... … . ……………… p50 ▪ FFP3 • FFP3 sans valve . …… . ……………… .. … . …… . ……… .. …………… . p52 • FFP3 avec valve ……… .. …………………… . ………… .. …………… . p53 o Masques lavables et personnalisables ………………………… . … .. p57 ▪ Modèle Ekotex …………… . ……… .... ………………………… . … . … p58 ▪ Modèle Chic & Ecolo ………………………………………… . …… . p59 ▪ Modèle AFNOR UNS1 (30 lavages) ……………… .. … p60 ▪ Modèle AFNOR UNS1 (40 lavages) …………………… .... p61 ▪ Modèle AFNOR UNS1 (50 lavages) …… . ……………… . … p62 ▪ Modèle AFNOR UNS2 (100 lavages) ……… .. … p63 o Autres … . …………………………………………………… . … . ……… . p64 ▪ Masque à visière . ……… .... ……………………… . ………… . ……… p65 ▪ Masque transparent … . …… . ……… . ……… .... ………… .. ……… p66
2
Document non contractuel
GANTS
Gants
7
Document non contractuel
Gant s Nitrile s Bleu
nitrile blue
examination, nitrile , non-sterile textured fingertips chlorinated beaded blue 1.0 • class I medical device • personal protective equipment category III
type external surface internal surface cuff colour AQL classification
features
increased tactile sensitivity
indication
100 pcs/ 10x100 pcs 200 pcs/ 10x200 pcs
packaging unit/ bulk packaging REF
a’100: RNB-xx-100 (xx:XS-XL) a’200: RNB-xx-200 (xx:XS-XL)
sizes
Gants Nitriles – Import Asie
Photos
8
Document non contractuel
Gants Nitriles – Import Asie
Spécifications
9
Document non contractuel
Gants Nitriles – Import Asie
Certificat CE
10
Document non contractuel
Gants Nitriles – Import Asie
Photos
11
Document non contractuel
Gants Nitriles – Stock Europe
Photos
Sans poudre – EN455, EN420, EN374
En raison de la forte demande actuelle, veuillez nous contacter en précisant la norme , la quantité et le délai de livraison souhaités. En effet, nous disposons de plusieurs stocks en Europe provenant de différents fournisseurs.
13
Document non contractuel
Gants Nitriles – Import Asie
Certificat CE
12
Document non contractuel
Gant Nitriles Autres couleurs
nitrile lime green
examination, nitrile , non-sterile textured fingertips chlorinated beaded lime green 1.5 • class I medical device • personal protective equipment category III
type external surface internal surface cuff colour AQL classification
features
pleasant, calming colour
indication
50 pcs/ 20x50 pcs RNBL03xx (xx:XS-XL)
packaging unit/ bulk packaging REF
sizes
nitrile pink
examination, nitrile , non-sterile textured fingertips chlorinated beaded dark pink 1.5 • class I medical device • personal protective equipment category III
type external surface internal surface cuff colour AQL classification
features
intense colour
indication
100 pcs/ 10x100 pcs RNBM03xx (xx:XS-XL)
packaging unit/ bulk packaging REF
sizes
Gant Nitriles Autres couleurs
examination, nitrile , non-sterile textured fingertips chlorinated beaded black 1.0 • class I medical device • personal protective equipment category III
type external surface internal surface cuff colour AQL classification
features
masking colour, increased endurance
indication
100 pcs/ 10x100 pcs RNBC03xx (xx:XS-XL)
packaging unit/ bulk packaging REF
sizes
nitrile pink
examination, nitrile , non-sterile textured fingertips chlorinated beaded light pink 1.5 • class I medical device • personal protective equipment category III
type external surface internal surface cuff colour AQL classification
features
pleasant, calming colour
indication
100 pcs/ 10x100 pcs RNBR03xx (xx:XS-L)
packaging unit/ bulk packaging REF
sizes
Gant Latex
latex
examination, latex , non-sterile textured powdered beaded natural latex 1.5 • class I medical device • personal protective equipment category III
type external surface internal surface cuff colour AQL classification
features
standard latex glove
indication
100 pcs/ 10x100 pcs RLP03xx (xx:XS-XL)
packaging unit/ bulk packaging REF
sizes
latex PF
examination, latex , non-sterile textured powder-free, polymer-coated beaded natural latex 1.5 • class I medical device • personal protective equipment category III
type external surface internal surface cuff colour AQL classification
features
easier donning due to inner polymer coating
indication
100 pcs/ 10x100 pcs RLB03xx (xx:XS-XL)
packaging unit/ bulk packaging REF
sizes
Gant Vinyl
vinyl
examination, vinyl , non-sterile smooth powdered beaded transparent 1.5 • class I medical device • personal protective equipment category III
type external surface internal surface cuff colour AQL classification
indication
100 pcs/ 10x100 pcs RWP07xx (xx:XS-XL)
packaging unit/ bulk packaging REF
sizes
vinyl PF
examination, vinyl , non-sterile smooth powder-free beaded transparent 1.5 • class I medical device • personal protective equipment category III
type external surface internal surface cuff colour AQL classification
indication
100 pcs/ 10x100 pcs RWB07xx (xx:XS-XL)
packaging unit/ bulk packaging REF
sizes
simple vinyl The instruction below should be used in conjunction with detailed information on the packaging.
Short description of the product Vinyl protective gloves, powder-free or powdered, non-sterile for disposable use, for minimal risk Full description of the product Reference number:
Intended use These are non-sterile protective gloves, intended for use in hygienic and sanitary works in public places, for maintaining cleanness in facilities, utility rooms and home, professional cleaning services using cleaning materials of weak action, gardening, agriculture, food processing and food contact, for use in household and mechanical works with risk only superficial mechanical injury. Classified as Personal Protective Equipment category I for minimal risk. Their design and labeling corresponds to the requirements of the Regulation 2016/425 on Personal Protective Equipment. Gloves should be used solely according to their intended purpose. Precautions and indications for use Dry hands before putting the gloves on. Before usage, inspect the gloves for any defect or imperfections. If the gloves get punctured, torn or broken during their use, take them off and put on the new ones. Avoid using gloves dirty in the inside as they may cause irritation leading to skin inflammation or more serious damages. The gloves should not be used in contact with open fire and to protect against any sharp tools. The gloves are not intended for welding, electric shock protection, ionizing radiation or from the effect of hot or cold objects. Components / hazardous components Some gloves may contain components known to be a possible cause of allergy for person allergic to them, who may develop contact irritation and/or allergic reaction. In the case of an allergic reaction, seek medical assistance immediately. Disposal Used gloves should be disposed of in accordance with local regulation. Gloves should be buried or burned under controlled conditions.
: RP20018001 - 05 (1537) RP20017001- 05 (1537) lub (0010) RP20016001 - 05 (1537) lub (0010) RP21015001 - 05 (1537) lub (0010) : vinyl : beaded : black / blue / clear : ambidextrous, fitting either hand : XS (5-6), S (6-7), M (7-8), L (8-9), XL (9-10) : 100 pcs. by weight
Raw material Cuff
Colour Shape Size range Quantity in packaging Shelf life
: 5 years for powdered gloves 3 years for powder-free gloves
Storage instructions It is recommended to store the gloves in dry place, in the temperature of 5-35 °C and to protect them against direct sunlight and fluoresce nt light. It is recommended to protect gloves against humidity. Keep the gloves in a distance of not less than 1m from heating devices, sources of fire and ozone. Do not keep in direct vicinity of solvents, oils, fuels and lubricants. Food contact Gloves are marked with food contact symbol and comply with the requirements of Regulation (EU) No 10/2011, European Regulation (EC) No 1935/2004 and with Regulation (EC) No 2023/2006 on Good Manufacturing Practice.
Manufacturer
MERCATOR MEDICAL S.A. ul. H. Modrzejewskiej 30 31-327 Cracow, Poland www.mercatormedical.eu
PPE classification & compliance Gloves are classified as Personal Protective Equipment – category I for minimal risk according to the Regulation 2016/425. Compliance with standards: EN 420:2003+A1:2009.
Declaration of Conformity can be found under below web address: https://en.mercatormedical.eu/
Date:02-11-2021, Rev. 2.2
Symbols used on the packaging
Personal Protective Equipment
Medical device
Powdered gloves
Do not re-use / gloves are intended for single use
Keep away from moisture, store in a dry place
Powder free gloves
Keep away from solar and fluorescent light
Presence of polymer coating on the inner surface of the glove
Non-sterile gloves
Temperature limitation / gloves store in temperature 5-35 °C
Presence of cosmetic coating on the inner surface of the glove
Lot / batch number
Presence of external texture on the glove
Catalogue number
Keep away from ozone
EU Authorised Representative, symbol should be accompanied by name and address of Authorised Representative
Date of manufacture
Gloves made from nitrile
Manufacturer, symbol should be accompanied by name and address of Manufacturer
Gloves do not contain natural rubber latex
Expiry date
Food contact symbol (article is suitable for food contact, for details check the instruction for use)
Marking of gloves protecting against bacteria and fungi
Gloves made from vinyl
Marking of gloves protecting against viruses, bacteria and fungi
Package made from paper, qualify for recycling
Raw material – natural rubber latex
Marking of type A chemical resistant gloves. Six tested
Package is treated as municipal waste
50 gloves by weight
chemicals shall be identified by their code letter under pictogram
Marking of type B chemical resistant gloves. Three tested chemicals shall be identified by their code letter under pictogram
Consult instructions for use
100 gloves by weight
Marking of type C chemical resistant gloves. One tested
Information in other languages inside
200 gloves by weight
chemicals shall be identified by their code letter under pictogram
Indicates compliance with the requirements of Russian market
Indicates compliance with the requirements of Ukrainian market
Do not use, if package is damaged
Date:02-11-2021, Rev. 2.2
Date:02-11-2021, Rev. 2.2
MASQUES JETABLES
Masques Jetables
14
Document non contractuel
3 plis chirurgicaux - Type I
PHOTOS
15
Document non contractuel
3 plis chirurgicaux - Type I
FICHE TECHNIQUE
16
Document non contractuel
3 plis chirurgicaux - Type I
PHOTOS
17
Document non contractuel
3 plis chirurgicaux - Type I
DÉCLARATION DE CONFORMITÉ CE
18
Document non contractuel
3 plis chirurgicaux - Type I
PHOTOS
Dimensions : 17,5 cm x 9,5 cm
Packaging : 50 masks / box
19
Document non contractuel
3 plis chirurgicaux - Type I
DÉCLARATION DE CONFORMITÉ CE
20
Document non contractuel
3 plis chirurgicaux - Type I
RAPPORT DE TEST
21
Document non contractuel
3 plis chirurgicaux - Type I
PHOTOS
22
Document non contractuel
3 plis chirurgicaux - Type I
CERTIFICAT D'ENREGISTREMENT CE
23
Document non contractuel
3 plis chirurgicaux - Type I
RAPPORT DE TEST
24
Document non contractuel
3 plis chirurgicaux - Type II
PHOTOS
25
Document non contractuel
3 plis chirurgicaux - Type II
PHOTOS
26
Document non contractuel
3 plis chirurgicaux - Type II
DÉCLARATION DE CONFORMITÉ CE
27
Document non contractuel
3 plis chirurgicaux - Type IIR
PHOTOS
28
Document non contractuel
3 plis chirurgicaux - Type IIR
RAPPORTS D’ESSAIS
29
Document non contractuel
3 plis chirurgicaux - Type IIR
PHOTOS
30
Document non contractuel
3 plis chirurgicaux - Type IIR
FICHE TECHNIQUE
31
Document non contractuel
3 plis chirurgicaux - Type IIR
FICHE TECHNIQUE
32
Document non contractuel
3 plis chirurgicaux - Type IIR
PHOTOS
33
Document non contractuel
3 plis chirurgicaux - Type IIR
FICHE TECHNIQUE
DETAILS
CONDITIONNEMENT
34
Document non contractuel
3 plis chirurgicaux - Type IIR
DECLARATION DE CONFORMITE CE
35
Document non contractuel
3 plis chirurgicaux - Type IIR
RAPPORT DE TEST
36
Document non contractuel
Masques FFP2 emballage individuel
Master Carton Weight * Gewicht des Umkarton Master Carton Size * UmkartongrôBe Pieces in Master Carton * Stücke im Umkarton Master Carton in 1 Pallet
1 12,00 kg
1 595 x 395 x 610
1 1
7200 pcs
76 Box
* Umkarton in 7 Pallet Number of Product in 1 Pallet 1
79.200 pcs
* Produktanzahl in 7 Palette Number of Pallets in 1 Truck
1 33 pcs
* Anzahl Paletten in 7 LKW Number of Product in 1 Truck 1 633.600 pcs * Produktanzah l in 7 LKW
PARTICLE FILTERING HALF MASK KF-A F10(SC) EN 149:2001+A1:2009 FFP2 NR White/Green/Black
ISO 9001 Certification QUALITY CONTROL SYSTEM CERTIFICATION
06
ISO 13485 Certification QUALITY CONTROL SYSTEM CERTIFICATION
07
ISO 17025 Certification QUALITY CONTROL SYSTEM CERTIFICATION
08
CE Certification
09
10
SGS Certification
11
TEST REPORTS
12
13
14
15
16
17
18
19
20
21
EU DECLARATION OF CONFORMITY
22
23
PACKING INFORMATION
DE
Inner Bag White/Green/Black - Size:125*140mm
1
pc/bag
Paper Box - Size:140*35*125mm
6
pcs/box
Carton
- 200 boxes/carton - Size:575*370*650mm - Gross weight:15500±500g
1200 pcs/caton
The actual product you receive may be (slightly) different from this photo please make the object as the standard
STORAGE AND DISPOSAL
24
PACKING INFORMATION EN DE FIN SE White/Green/Black
Paper Box - Size:140*40*121mm
10 pcs/box
Carton
- 120 boxes/carton - Size:510*435*440mm - Gross weight:13500±500g
1200 pcs/caton
The actual product you receive may be (slightly) different from this photo please make the object as the standard
STORAGE AND DISPOSAL
25
PACKING INFORMATION EN DE FIN SE White
Paper Box - Size:135*120*121mm
30 pcs/box
Carton
- 40 boxes/carton - Size:625*285*505mm - Gross weight:12500±500g
1200 pcs/caton
The actual product you receive may be (slightly) different from this photo please make the object as the standard
STORAGE AND DISPOSAL
26
FFP2 - KN95 sans valve
PHOTOS
37
Document non contractuel
FFP2 - KN95 sans valve
PHOTOS
38
Document non contractuel
FFP2 - KN95 sans valve
FDA - DÉCLARATION D'ENREGISTREMENT
39
Document non contractuel
FFP2 - KN95 sans valve
CERTIFICAT DE CONFORMITÉ
40
Document non contractuel
FFP2 - KN95 sans valve
RAPPORT DE TEST
41
Document non contractuel
FFP2 - KN95 sans valve
RAPPORT DE TEST
42
Document non contractuel
FFP2 – FFP2 sans valve
PHOTOS
43
Document non contractuel
FFP2 – FFP2 sans valve
PHOTOS
Disposable Respirator FFP2 – 3-panel design
44
Document non contractuel
FFP2 – FFP2 sans valve
RAPPORT DE TEST
45
Document non contractuel
FFP2 – FFP2 sans valve
CERTIFICAT UE
46
Document non contractuel
FFP2 – FFP2 sans valve
PHOTOS
Disposable Respirator FFP2 – 2-panel flat fold masks
47
Document non contractuel
FFP2 – FFP2 sans valve
RAPPORT DE TEST
48
Document non contractuel
FFP2 – FFP2 sans valve
CERTIFICAT UE
49
Document non contractuel
FFP2 – FFP2 avec valve
PHOTOS
FFP2 NR D (sans valve)
FFP2 NR D (avec valve)
50
Document non contractuel
FFP2 – FFP2 avec valve
DÉCLARATION DE CONFORMITÉ UE
51
Document non contractuel
PARTICLE FILTERING HALF MASK FFP3 KF-G F03V EN149:2001+A1:2009
Easy pull adjustable headband, convenient and solid for use.
Velvet inner side , Fit to face, More Comfortable and higher Compactability.
the packing may update,please make the object as the standard
Report No.: NKG2020050401
Supplier Creditability & Capacity Audit Report
Report: Supplier Name
Guangdong KINGFA SCI.&TECH. Co., Ltd.
No. 28, Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province, China
Supplier Address
Client Information
/
Name of Assessor James Lee
Reviewed by
Roger Wang
Audited Date
04 May, 2020
Expiry Date
03 May, 2021
Assessment Scope: Section 1: Company Profile Section 2: Personnel Section 3: Main Market Section 4: Manufacturing Ability Section 5: Certificate Section 6: Quality Control Management Section 7: Development Plan Section 8: Production Flow Chart Section 9: Attachment
Comments Guangdong KINGFA SCI.&TECH. Co., Ltd. is a trader and manufacturer combined company with 2097 employees; it was established in 2013, located in No. 28, Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province, China. They have passed ISO9001, ISO14001, OHSAS18001 certifications in 2017. Guangdong KINGFA SCI.&TECH. Co., Ltd. has successful foreign trading experience in Europe, North America and East Asia. Important Notes: This report is issued by the SGS –CSTC under its General Terms and Conditions of Service accessible at http://www.sgs.com/terms_and_conditions.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s actual findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law.
Page No.: 1 of 19
Report No.: NKG2020050401
Section 4: Manufacturing Ability
4.1 Main Facilities
Facility name
Brand/Model
Quantity
Year made
Condition
Medical Mask Production Line
Please list the major machinery / utilities on site.
Guoji
132
2020
Good
Protective Mask Production Line
Kuaiyuda
80
2020
Good
4.2 Main Test Instruments
Facility name
Brand/Model
Quantity
Year made
Condition
Mask BFE Tester
ZR-1000
1
2020
Good
Mask Tensile Strength Tester
KT22
1
2020
Good
Please list the major test instruments on site.
Clean Bench
YJ-840
1
2020
Good
Mildew Incubator
MJ-80
1
2020
Good
Constant Temperature Incubator
DHP-9082
1
2020
Good
4.3 Output
Product
Monthly output
Yearly output
Output in last year
N/A
N/A
N/A
Protective Mask/ Medical Mask (Non-sterile) / ( )
300,000,000 Pcs
N/A
Output in this year
Page No.: 6 of 19
Report No.: NKG2020050401
Section 5: Certificate
5.1 Management System Certificate
Certificate
Number
Expiry date
Certifying Body
Scope
01 100 1430282
ISO 9001:2015
31 Oct., 2017
TUV Rheinland
Design and production of modified plastics
ISO14001:2004 01 104 1430282
18 Jul., 2020
TUV Rheinland
Design and production of modified plastics
OHSAS 18001:2007
01 113 1430282
18 Jul., 2020
TUV Rheinland
Design and production of modified plastics
5.2 Product Certificate
Certificate
Number
Issued date
Certifying Body
Product and model / type
Disposable medical mask(non-sterile) Standard EN14693:2019+ac:2019
20R000099 MT
23 Apr. 2020
GTT
Test Report
Jiangsu Guojian Testing Technology Co., Ltd.
(2020) WSZ FHL No. 2852
Labor Protective Mask Standard: GB2626-2006
27 Mar., 2020
Test Report
Disposable Protective Mask Model: Adult; Protective Mask Model: KF-A(Adult)
FDA Registration
10065634
FDA
2020
Page No.: 7 of 19
Report No.: NKG2020050401
Section 6: Quality Control Management
Grading
Item
Content
Observations /Comments
Poor
Mid
Good
Are the environmental conditions such as tidiness and cleanliness being controlled and suitable for the operation performed? Are the following items /documents provided at appropriate location and under control when necessary? - Work Instructions /procedures - Workmanship standard /acceptance - Golden sample Does the company establish and implement an effective suppliers/ sub-contractors assessment procedure (which covers the acceptable criteria of supplier/ sub-contractor)? Are written instructions available for incoming material inspections /testing? Is the relevant records maintained? Are written inspections /testing instructions available for finished products? Is the relevant records maintained? Is there a procedure to conduct random product inspection after final packaging in place? Are non-conforming units clearly marked/ segregated to prevent accidental dispatch? Is there a clear procedure for handling customer complaint? Can the finished/packaged product be traced by lot identification to the appropriate raw materials test reports? Are corrective & preventive actions mechanism established and implemented effectively (including the suppliers/ sub-contractors’ control, incoming inspection, process control, final inspection and customer complaint)?
Refer to site observation; the environmental condition was suitable for the operation performed. Refer to site observation; there were documented work instructions, workmanship standard provided in the workshops.
6.1
6.2
The company had established this procedure for supplier assessment, latest record has been reviewed.
6.3
Refer to on-site observation; there were documented instructions for incoming material inspection. And inspection records were maintained well. The company had established the procedure for this inspection. And records were maintained well.
6.4
6.5
All inspection procedures were implemented before packaging.
6.6
Refer to site observation; non-conforming units would be marked with label and placed in the non-conforming parts area Refer to relevant documentation; the company had a clear procedure for handling customer complaint. Auditor noted that the company had established this procedure for lot identification. The company had documented procedure for corrective & preventive actions mechanism and records were kept well.
6.7
6.8
6.9
6.10
Page No.: 8 of 19
Report No.: NKG2020050401
Section 8: Production Flow Chart
8.2 Product: Solar Module
1. Medical Mask (Non-sterile) Production
2. Protective Mask Production
3. Lab. Testing
N/A
4.Packing
5. Store
N/A
Page No.: 10 of 19
Report No.: NKG2020050401
Section 9: Attachment
9.1 Photos of Document and Certificate Business License
Medical Device Production License
Medical Device Registration Certificate
Medical Device Registration Certificate
Export License
Land Certificate
Page No.: 11 of 19
Report No.: NKG2020050401
ISO9001 Certificate
ISO14001 Certificate
OHSAS18001 Certificate
Verification of Conformity
Registration in German Safety Office for Medical Devices
FDA Registration
Page No.: 12 of 19
Report No.: NKG2020050401
Testing Report
Testing Report
Testing Report
Testing Report
Page No.: 13 of 19
Report No.: NKG2020050401
9.2 Photos of Company and Product Sample Company Gate
Office Building
Office
Lab.
Testing Machine
Testing Machine
Page No.: 14 of 19
Report No.: NKG2020050401
Workshop Building
Workshop Building
Workshop
Workshop
Automatic Production line
Automatic Production line
Page No.: 15 of 19
FFP3 – FFP3 sans valve
PHOTOS
Modèle pliable
Modèle coque
52
Document non contractuel
FFP3 – FFP3 avec valve
PHOTOS
FFP3 NR D (with valve)
53
Document non contractuel
FFP3 – FFP3 avec valve
DÉCLARATION DE CONFORMITÉ UE
54
Document non contractuel
FFP3 – FFP3 avec valve
PHOTOS
FFP3 NR D (with valve)
55
Document non contractuel
FFP3 – FFP3 avec valve
DÉCLARATION DE CONFORMITÉ UE
56
Document non contractuel
MASQUES LAVABLES & PERSONNALISABLES
Masques lavables et personnalisables
57
Masques lavables et personnalisables
Modèle EKOTEX
- - -
2 couches 100% coton (2 x 150 g/m²)
Tissu(s)
Emplacement pour filtre
Option : Filtre F9
Couleur(s)
- Blanc, noir, rouge, bleu marine (prix identiques pour la couleur)
- -
10-30 lavages minimum (en usage normal)
Entretien
Lavage à 60°C
- Emballage par 20/30/50 pièces dans des sachets plastiques scellés - 2500 à 3000 masques par carton
Emballage
Production / Stock
- Volume de production : 30 000 masques par semaine
Origine
-
Union européenne
Personnalisation
- Personnalisable (logos et/ou couleurs) à partir de 2000 pièces
Illustrations
58
Document non contractuel
Masques lavables et personnalisables
Modèle CHIC & ECOLO
-
2 couches 100% coton (2 x 120 g/m²) ou 2 couches de coton 60%/polyester 40%.
Tissu(s)
- - -
Barre ajustable au nez Emplacement pour filtre
Filtre optionnel : 0,30 € HT/unité
Couleur(s)
-
Grand choix de couleurs
Dimensions
-
8 cm x 18 cm
- -
10-30 lavages minimum (en usage normal)
Entretien
Lavage à 60°C
- Soumis à une température de 150 degrés avant l'emballage. - Emballage de 10 à 100 masques
Emballage
Production / Stock
- Volume de production : 20 000 masques par jour
Origine
-
Union européenne
Personnalisation
- Personnalisable (logos et/ou couleurs) à partir de 2000 pièces
Illustrations
59
Document non contractuel
Masques lavables et personnalisables
Modèle AFNOR S76-001 UNS1 – 30 Lavages
3 couches : - 2 couches 100% coton + 1 couche tissu antibactérien - 2 couches 65% polyester/35% coton + 1 couche tissu antibactérien (pour le modèle avec motifs)
Tissu(s)
Couleur(s)
- Blanc, couleurs et imprimés (aux mêmes tarifs)
- -
30 lavages minimum
Entretien
Lavage à 60°C
Dimensions
-
Tailles adultes et enfants
Emballage
-
Emballages individuels
- -
500 000 masques de chaque couleur en stock Production de 5 ou 6 millions par mois
Production / Stock
Origine
-
France
Personnalisation
-
Personnalisable à partir de 500 pièces
Illustrations
60
Document non contractuel
Masques lavables et personnalisables
Modèle AFNOR S76-001 UNS1 – 40 Lavages
- - -
100% polypropylène non tissé
Tissu(s)
Tissu très léger et doux
Testé et validé par la DGA : UNS1 - 40 lavages
Couleur(s)
-
Blanc
Dimensions
-
190 x 95 mm
- -
40 lavages minimum
Entretien
Lavage à 60°C
Emballage
- Emballage individuel ou 10 masques par paquet
Production / Stock
-
50 000 masques / jour
Origine
-
Union européenne
Personnalisation
- Personnalisable (logos et/ou couleurs) à partir de 500 pièces
3 plis Bande élastique derrière chaque oreille, barre réglable sur le haut du masque
Bec de canard Deux élastiques derrière la tête. Confort, respiration facile, faible brouillard sur les lunettes
Illustrations
61
Document non contractuel
Masques lavables et personnalisables
Modèle AFNOR S76-001 UNS1 – 50 Lavages
- Couches extérieures : Coton polyester (110 g/m²) - Couche intérieure : Polypropylène non tissé (50 g/m²) - Coutures et attaches : 100% Polyester (85 g/m²) - Testé et validé par la DGA : UNS1 - 50 lavages
Tissu(s)
Couleur(s)
-
Blanc, beige, gris, noir
Dimensions
-
190 x 95 mm
- - - -
50 lavages minimum
Entretien
Lavage à 60°C
10 masques par paquet
Emballage
Emballage individuel facultatif
Production / Stock
-
Stock de 150 000 unités
Origine
-
France
Personnalisation
- Personnalisable (logos et/ou couleurs) à partir de 2000 pièces
Illustrations
62
Document non contractuel
Masques lavables et personnalisables
Modèle AFNOR S76-001 UNS2 – 100 Lavages
- 1 couche de tissu 100% polyester + 2 élastiques - Léger, confortable et couvrant. - Testé et validé par la DGA : UNS2 - 100 lavages
Tissu(s)
- Blanc + Autres couleurs : Gris, Noir, Rouge, Bleu, Vert… (nous consulter pour le prix)
Couleur(s)
- - - - - - -
Taille Enfant (2-5 ans) : 15 x 8 cm Taille Junior (5-10ans) : 16,5 x 8 cm Taille Adulte (+10 ans) : 20 x 9 cm
Dimensions
Lavage à 60°C
Entretien
Filtration du tissu garantie 100 lavages
Sachet de 2 masques Carton de 100 masques
Emballage
Production / Stock
-
Stock disponible
Origine
-
France, UE, Maroc (selon les disponibilités)
Personnalisation
-
Personnalisables, nous contacter
Illustrations
63
Document non contractuel
AUTRES
64
Document non contractuel
MASQUE A VISERE
PHOTOS
65
Document non contractuel
MASQUE TRANSPARENT
PHOTOS
Spécification du produit : •
Couvre la bouche et le nez
• N'interfère pas avec la respiration libre • Ne provoque pas d'irritation • Fin film plastique de 0,2 mm • Très léger • Durera de nombreuses semaines • Emballé dans une boîte • Facile à désinfecter
66
Document non contractuel
S-1551 QUAITROVENTILS
* Mas � er Carton Weight Gew,cht des Umkarton Master Carton Size * UmkartongrôBe Pieces in Master Carton * Stücke im Umkarton Master Carton in 1 Pallet * Umkarton in 1 Pallet Number of Product in 1 Pallet * Produktanzahl in 7 Palette Number of Pallets in 1 Truck * Anzahl Paletten in 1 LKW Number of Product in 1 Truck * Produktanzah
l 17,00 kg l s70x390x570 l 144pcs l 16 Box l 2304pcs l 33 pcs
l in 1 LKW 76·032 pcs
S-1551 QUATTRO
Master Carton Weight * Gewicht des Umkarton Master Carton Size * UmkartongrôBe Pieces in Master Carton * Stücke im Umkarton Master Carton in 1 Pallet
1
77,00 kg
1 570 x 390 x 570
1 744 pcs
1
76 Box
* Umkarton in 7 Pallet Number of Product in 1 Pallet 1 2304 pcs * Produktanzahl in 7 Palette Number of Pallets in 1 Truck 1 33 pcs * Anzahl Paletten in 7 LKW Number of Product in 1 Truck 1 76 .032 pcs * Produktanzah l in 7 LKW
S-700MA3OR
Master Carton Weight * Gewicht des Umkarton Master Carton Size * Umkartongrc513e Pieces in Master Carton * Stücke im Umkarton Master Carton in 1 Pallet
1 75,00 kg
1 560 x 500 x 560
1 300 pcs
., .... , . - - • · ·····..• · · - ·· • """ · '•4·· ·
1 72 Box
* Umkarton in 1 Pallet Number of Product in 1 Pallet l 3_600 pcs * Produktanzahl in 1 Palette Number of Pallets in 1 Truck 133 pcs * Anzahl Paletten in 1 LKW Number of Product in 1 Truck 1 778_800 pcs * Produktanzahl in 1 LKW
SSASTRONOT
Master Carton Weight * Gewicht des Umkarton Master Carton Size * Umkartongrc513e Pieces in Master Carton * Stücke im Umkarton Master Carton in 1 Pallet
1 5,60 kg
1 600 x 400 x 400
1 500 pcs 1 24 Box
* Umkarton in 7 Pallet Number of Product in 1 Pallet 1 72.000 pcs * Produktanzahl in 7 Palette Number of Pallets in 1 Truck 1 32 pcs * Anzahl Paletten in 7 LKW Number of Product in 1 Truck 1384.000 pcs * Produktanzahl in 7 LKW
SMSBONNET
Master Carton Weight * Gewicht des Umkarton Master Carton Size * Umkartongrc5Be Pieces in Master Carton * Stücke im Umkarton Master Carton in 1 Pallet
1 5,60 kg
1 600 x 400 x 400
1 500 pcs 1 24 Box
* Umkarton in 7 Pallet Number of Product in 1 Pallet 1 72.000 pcs * Produktanzahl in 7 Palette Number of Pallets in 1 Truck 1 32 pcs * Anzahl Paletten in 7 LKW Number of Product in 1 Truck 1384.000 pcs * Produktanzahl in 7 LKW
SMS GOWN 40 GR.
Master Carton Weight * Gewicht des Umkarton Master Carton Size Umkartongrc513e Pieces in Master Carton * Stücke im Umkarton Master Carton in 1 Pallet *
1 70,80 kg
1 600 x 400 x 400
1 70
pcs
1 24 Box
* Umkarton in 7 Pallet Number of Product in 1 Pallet 1 7_680 pcs * Produktanzahl in 7 Palette Number of Pallets in 1 Truck 132 pcs * Anzahl Paletten in 7 LKW Number of Product in 1 Truck l so. 76 o pcs * Produktanzahl in 7 LKW
SS GOWN 40 GR.
Master Carton Weight * Gewicht des Umkarton Master Carton Size * Umkartongrc5Be Pieces in Master Carton * Stücke im Umkarton Master Carton in 1 Pallet
1 8,50 kg
1 600 x 400 x 400
1 70 pcs
1 24 Box
* Umkarton in 7 Pallet Number of Product in 1 Pallet 1 7_680 pcs * Produktanzahl in 7 Palette Number of Pallets in 1 Truck 132 pcs * Anzahl Paletten in 7 LKW Number of Product in 1 Truck l so. 76 o pcs * Produktanzahl in 7 LKW
COVID-19 Neutralizing Antibody Test Kit
1.For qualitative detection of the neutralizing antibody against novel coronavirus in Serum, plasma and whole blood from the People who have been vaccinated to determine whether it has a protective effect.
2.Quantitative detection of the neutralizing antibody against novel coronavirus in Serum, plasma and whole blood from the People who have been vaccinated to determine whether it has a protective effect and should vaccinate again or not.
The vaccine of COVID-19 generally needs two injections, and usually produces protective neutralizing antibodies about 7 days after the second injection. However, due to the difference of individual immunity, not everyone who has been vaccinated will produce neutralizing antibodies. Some people who have been infected with the COVID-19 also produce protective neutralizing antibodies. There are no definite evidence whether neutralizing antibodies can protect the mutated COVID-19. There are still lack of sufficient research on the protection period of neutralizing antibody.
Kit Contents
25pcs Test Cassettes 25pcs Droppers 25pcs lancets 25pcs Extraction buffer 25pcs Alcohol pad
Test Procedure
1
2
3
4
Remove theprotective cap fromtheblood lancet, place theendof lancet on the finger, push the thebuttonof the lancet downagainst the puncture site
squeeze theadequateamount of blood fromthe finger, absorb the bloodwith the transfer pipet fromthe topof theblood for testing(more than 50μl) (Note:Donot touch thewound directlywith the transfer pipet)
Preparation: After thekit reach20~26C, open thepouch just before test
Use the alcohol pad provided to clean the subject's finger
6
7
5
Transfer 2 drops (approximately 50 μl) of the blood into sample well(s).Adding more or less specimen may lead to erroneous results
Twist theheadof the specimendiluent vial off fromthenotch point andaddvertically 2drops(about 100μl) of wholeblooddiluent
Start the timer and read the test resultswithin15minutes. Donot interpret the result after 15minutes
Interpretation of Results
Positive
Negative
Invalid
POSITIVE: There are no line in the test line region (T), or the color of T-line is lighter then R-line. And the control line region (C) is appeared. NEGATIVE: The color of T-line is redder then R-line. And the control line region (C) is appeared. INVALID: Control line fails to appear. Insufficient sample volumes or incorrect procedures are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, the test kit should be discontinued of using immediately and your local distributor should be contacted.
Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)
For the qualitative detection of the antibodies of IgM/IgG against novel coronavirus in serum, plasma or whole blood from patients with clinical suspicion of COVID-19 infection. The antibody test kit is a product of the human immune response after infection with virus. In general, IgM antibodies appear early in the infection and IgG antibodies appear in middle and late stages on infection. Titers have a continuous increasing process and stay in blood circulation for longer time. The test for specific antibodies can determine whether a patient has “ recently or previously infected 2019-nCoV”.It helps to avoid “ False Negatives” to complementary to nucleic acid test. In the past 2020 LYHER® Novel Coronavirus(2019-nCov) IgM/IgG Antibody Combo Test Kit have been popular in more than 40 countries all over the world and passed a series of the certifications like EU CE, US FDA EUA, WHO EUL,French Ministry of Health, Malta MCCAA, Australia TGA, the Philippines FDA, Thai FDA, Brazil ANVISA and registered in Bolivia, Peru, Chile etc.
Product Features
CE Marked
Result in 10mins
Easy to collect samples
No equipment needed
Easy to read results
Room temperature storage
Clinical trials： Sensitivity: 96.37%, Specificity: 99.05%, Total coincidence rate: 97.88%(Kappa=0.957，P ＜ 0.001)
FDA EUA NCI Serology Test Evaluation repor
Measure
Estimate
Confidence Interval
IgM Sensitivity IgM Specificity IgG Sensitivity IgG Specificity
96.7% (29/30) 100% (80/80) 100% (30/30) 98.8% (79/80) 100% (30/30) 98.8% (79/80)
(83.3%; 99.4%) (95.4%; 100%) (88.7%; 100%) (93.3%; 99.8%) (88.7%; 100%) (93.3%; 99.8%) (40.9%; 96%)
Combined Sensitivity Combined Specificity
Combined PPV for prevalence = 5% Combined NPV for prevalence = 5%
80.8%
100% (99.4%; 100%)
(99.4%; 100%)
Cross-reactivity with HIV+
0.0% (0/10) not detected
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