FDA 510(k)

039 Surgical Face Mask

K-Number: K211956 · 2021-11-23

Decision Date2021-11-23

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

039 Surgical Face Mask is a medical device manufactured by Aok Tooling Limited. It received FDA 510(k) clearance on 2021-11-23 under approval number K211956. 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 039 Surgical Face Mask?

039 Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-11-23. It is manufactured by Aok Tooling Limited. The 510(k) number is K211956.

When was 039 Surgical Face Mask approved by the FDA?

039 Surgical Face Mask received FDA 510(k) clearance on 2021-11-23, under approval number K211956.

What company makes 039 Surgical Face Mask?

039 Surgical Face Mask is manufactured by Aok Tooling Limited.

What is the FDA product code for 039 Surgical Face Mask?

The FDA product code for 039 Surgical Face Mask is FXX.

Other Devices by Aok Tooling Limited

K201517Plain Surgical Mask K220876AOK 95A Medical Mask (20200049)

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.