Cleared Traditional

ProGear? Surgical Mask with Oxafence?, Model AV82030

K231741 · Prestige Ameritech · General Hospital
Sep 2024
Decision
449d
Days
Class 2
Risk

About This 510(k) Submission

K231741 is an FDA 510(k) clearance for the ProGear? Surgical Mask with Oxafence?, Model AV82030, a Surgical Mask With Antimicrobial/antiviral Agent (Class II — Special Controls, product code OUK), submitted by Prestige Ameritech (North Richland Hills, US). The FDA issued a Cleared decision on September 5, 2024, 449 days after receiving the submission on June 14, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K231741 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2023
Decision Date September 05, 2024
Days to Decision 449 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

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.