Product Information Sheet: Non-Surgical Isolation Gowns

3M non-surgical isolation gownProduct Information

Product description: Non-surgical isolation gowns (disposable)

Product group: Personal Protective Equipment

Demand1

Usage guidance: Mostly single use, can be re-worn by healthcare professionals if treating known COVID-19 patients

Current availability: Low

Manufacturing

Technologies required to manufacture: Polypropylene spunbond and meltblown extrusion, heat press, and assembly

Degree of automation: Fully automated for most large manufacturers, smaller manufacturers may use labor (e.g., stitching and cutting)

Regulatory & compliance validation process difficulty: N/A

FDA Classification: Class 1 – 510(k) exempt

Raw material availability: Various (polypropylene, polyester, polyethylene, cotton, blends)

Raw material shortages: Intermediate Spun bond- Melt blown-Spun bond (SMS) nonwoven

Design Requirements2

  • Isolation gowns (non surgical / non sterile)
  • Disposable, common sizes: S, M, L, XL
  • Tear resistant, strong seams, low lint, breathability
  • Length: ideally to mid-calf
  • Back: open or closed (not mandated by CDC)

Standards:

  • US: ANSI / AAMI PB70 Level 1 and Level 2 for liquid barrier performance
  • European: EN13795, EN14126
  • ASTM F4207 for testing of surgical gowns

Back to Overview


1. FDA Medical PPE for infection control

2. CDC PPE COVID 19 guidance (3/23/2020)

Source: CDC; FDA

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