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510(k) K192105

Innonix Antiviral Child's Face Mask by Innonix Technologies Limited — Product Code OUK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2019
Date Received
August 5, 2019
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.

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  • K101128 — BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF (May 26, 2011)