Face Masks • Masks Standards
Masks Standards
Made-in-USA and Made-in-Italy face masks that meet EN 14683 Type and ASTM Level classifications. Selecting the appropriate mask for a particular procedure is a critical component of your Personal Protective and Patient Protection Equipment (PPE) protocol. Although masks may look similar, each mask has notable differences affecting its level of protection. Understanding EN14683 and ASTM performance can help ensure your mask will provide appropriate protection to minimize the spread of potentially infectious diseases.
EN14683 Classification
TYPE IIR (Enhanced Fluid Resistance, ASTM Level 3) Ideal for procedures where heavy to moderate amounts of fluid, spray and/or aerosols are produced. • Complex oral surgery
TYPE IIR
TYPE II
Procedures
Ideal for procedures where light amounts of fluid, spray and/or aerosols are produced • Patient exams • Operatory cleaning • Impressions • Lab finishing & polishing • Orthodontics
Ideal for procedures where moderate to light amounts of fluid, spray and/ or aerosols are produced. • Limited oral surgery
• Crown preparation • Implant placement • Periodontal surgery
• Endodontics • Prophylaxis • Restorative • Sealant
• Use of ultrasonic scalers • Laser based applications 2
Fluid resistance, kPa (mm Hg)
21.3 (160)
16.0 (120)
Not Required
BFE, @ 3 microns
≥98%
≥98%
≥98%
Delta P, Pa/cm 2 (mm H2O/cm 2 )
< 49.0 (<5)
< 49.0 (<5)
< 29.4 (<3)
Microbial Cleanliness, cfu/g
< 30
< 30
< 30
Level 3
Level 2
Level 1
Additional ASTM 2100 Classification
PFE, @ 0.1 micron
≥98%
≥98%
≥95%
Flame spread
Class 1
Class 1
Class 1
Fluid resistance, kPa (mm Hg)
21.3 (160)
16.0 (120)
10.7 (80)
Delta P, Pa/cm2 (mm H2O/cm 2 )
< 49.0 (<5)
< 39.2 (<4)
< 29.4 (<3)
Product families meeting both EN14683 & ASTM classifications
Ultra™ Masks Ultra™ Sensitive Masks Ultra™ Sensitive Masks with BIOSAFE ®
Procedural Surgical Tie-On
Isofluid™ Masks Isofluid™ Plus Masks Le Petit Mask
B304
FILTRATION LEVEL KEY
EN 149: 2001 FFP2 NR Type IIR Enhanced Fluid Resistance ASTM 3 Type IIR ASTM 2 Type II ASTM 1
Minimum Performance
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