Product Information Sheet: Surgical Masks

3M Tie-on Fluid-Resistant Traditional Flat Pleated Surgical MaskProduct Information

Product description: Surgical masks (these are NOT the same as patient/Isolation masks and face masks)

Product group: Personal Protective Equipment

Demand

Usage guidance: Not intended to be used more than once; discard if damaged, soiled, or if breathing through mask becomes difficult

Current availability: Very low

Manufacturing

Technologies required to manufacture: Polypropylene, typically 2-3 layers; usually in a SMS form

Degree of automation: Fully automated by large players, but for smaller players the final assembly may be manual (seamstresses)

Regulatory & compliance validation process difficulty: Moderate

FDA Classification: Class II2

Raw material availability: polypropylene, polystyrene, polycarbonate, polyethylene

Raw material shortages: High quality meltblown nonwoven

Design Requirements1

Requirement Level 1 Level 2 Level 3 Description
Fluid protection resistance >80 mmHg >120mmHg >160 mmHg Resistance to penetration by synthetic blood
Differential pressure test <4.0 <5.0 <5.0 Breathing pressure difference across the mask
BFE (bacteria filtration efficiency standard: 3 μm) >=95% >=98% >=98% Ability of the mask to prevent the passage of aerosolized bacteria
PFE (particle filtration efficiency standard: 1 μm) >=95% >=98% >=98% Filtration test using unnaturalized 0.1 micron Polystyrene Latex Spheres

 

Standards: Surgical masks are regulated under 21 CFR 878.4040.

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1. ASTM levels determined by ASTM F2100-11 standards, ASTM F1862, ASTM F2299

2. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/surgical-masks-premarket-notification-510k-submissions

Source: https://www.cdc.gov/coronavirus/2019-ncov/hcp/index.html; https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirator-use-faq.html; image courtesy of 3M; Image source: 3M.com

WORKING DOCUMENT, SUBJECT TO CHANGE. NOT EXHAUSTIVE.

DOCUMENT INTENDED TO PROVIDE INSIGHT BASED ON CURRENTLY AVAILABLE INFORMATION FOR CONSIDERATION AND NOT SPECIFIC ADVICE.