Product Information Sheet: Disposable Surgical N95 Respirators

Disposable Surgical N95 RespiratorProduct Information

Product description: Surgical N95 respirators, e.g., 3M 8210 and 9210

Product group: Personal Protective Equipment

Demand

Usage guidance: Designed for single use.1 Limited single-wearer re-use considered in contingency scenarios.2

Current availability: Very low

Manufacturing

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

Design Requirements2

  • 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

Back to Overview


1. https://www.cdc.gov/niosh/npptl/pdfs/UnderstandingDifference3-508.pdf

2. https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/contingency-capacity-strategies.html

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.