FDA 510(k)

KNH Surgical Face Mask

K-Number: K203528 · 2022-11-16

Decision Date2022-11-16

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

KNH Surgical Face Mask is a medical device manufactured by Knh Surgical Face Mask. It received FDA 510(k) clearance on 2022-11-16 under approval number K203528. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KNH Surgical Face Mask?

KNH Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2022-11-16. It is manufactured by Knh Surgical Face Mask. The 510(k) number is K203528.

When was KNH Surgical Face Mask approved by the FDA?

KNH Surgical Face Mask received FDA 510(k) clearance on 2022-11-16, under approval number K203528.

What company makes KNH Surgical Face Mask?

KNH Surgical Face Mask is manufactured by Knh Surgical Face Mask.

What is the FDA product code for KNH Surgical Face Mask?

The FDA product code for KNH Surgical Face Mask is FXX.

Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.