Product description: Surgical N95 respirators, e.g., 3M 8210 and 9210
Product group: Personal Protective Equipment
Current availability: Very low
Technologies required to manufacture: Polypropylene spunbond and meltblown extrusion, heat press & assembly
Degree of automation: Fully automated by large players, but for smaller players the final assembly may be manual (seamstresses)
FDA Classification: Class 2, if surgical3—may be 510(k) exempt
Regulatory & compliance validation process difficulty: Medium
Raw material availability: High quality polypropylene likely available; intermediate Spunbond Meltblown Spunbond (SMS) nonwoven, especially the quality meltblown in short supply
Raw material shortages: N95 quality meltblown nonwoven
- Grade N95
- Good breathability with a design that does not collapse against the mouth (e.g. duckbill, cup shaped).
Standards: Minimum "N95" respirator according to FDA Class II, under 21 CFR 878.4040; evaluated, tested, and approved by NIOSH as per 42 CFR Part 84
3. Per WHO technical guidance COVID-19 v4 (11 Mar 2020) 4. Non healthcare N95 respirators (e.g., for use in construction and in dustrial settings) are regulated by the NIOSH in the US
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
WORKING DOCUMENT, SUBJECT TO CHANGE. NOT EXHAUSTIVE.
DOCUMENT INTENDED TO PROVIDE INSIGHT BASED ON CURRENTLY AVAILABLE INFORMATION FOR CONSIDERATION AND NOT SPECIFIC ADVICE.