Cleared Traditional

BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013

K101128 · Filligent Limited · General Hospital
May 2011
Decision
399d
Days
Class 2
Risk

About This 510(k) Submission

K101128 is an FDA 510(k) clearance for the BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013, a Surgical Mask With Antimicrobial/antiviral Agent (Class II — Special Controls, product code OUK), submitted by Filligent Limited (Austin, US). The FDA issued a Cleared decision on May 26, 2011, 399 days after receiving the submission on April 22, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K101128 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2010
Decision Date May 26, 2011
Days to Decision 399 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code OUK — Surgical Mask With Antimicrobial/antiviral Agent
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040
Definition 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.