Product 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.
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.