• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device n95 respirator with antimicrobial/antiviral agent
Regulation Description Surgical apparel.
Definition A single use, disposable, niosh-approved respirator intended for occupational use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions.
Physical State The device is an N95 respirator composed of at least 3 layers of filtration material with bands or ties to secure it to the head, a flexible noseband to insure a close fit and an added, specified antimicrobial and/or antiviral agent added to the respirator.
Technical Method Device uses a combination of tight facial fit and filtration to help reduce exposure to particulate aerosols plus the addition of an antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions
Target Area The device is worn over the nose and mouth and is intended to protect the respiratory tract from hazardous particulates
Regulation Medical Specialty General & Plastic Surgery
Review Panel General Hospital
Product CodeONT
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 878.4040
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
-
-