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510(k) K101128

BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013 by Filligent Limited — Product Code OUK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2011
Date Received
April 22, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Mask With Antimicrobial/Antiviral Agent
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

A single use, disposable surgical mask for occupational use to cover the nose and mouth of the wearer to protect from the transfer of microorganisms,body fluids and particulates and has an added antimicrobial and/or antiviral agent which kills specific pathogens under specified contact conditions.

Other clearances by Filligent Limited

  • K122702 — BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR (March 18, 2013)

Other clearances for product code OUK

  • K231741 — ProGear® Surgical Mask with Oxafence®, Model AV82030 (September 5, 2024)
  • K192105 — Innonix Antiviral Child's Face Mask (November 29, 2019)
  • K182766 — Cufitec Surgical Mask (January 3, 2019)