Product description: Surgical masks (these are NOT the same as patient/Isolation masks and face masks)
Product group: Personal Protective Equipment
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
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
|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.
1. ASTM levels determined by ASTM F2100-11 standards, ASTM F1862, ASTM F2299
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.