FDA 510(k)

Plain Surgical Mask

K-Number: K201517 · 2020-09-04

Decision Date2020-09-04

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Plain Surgical Mask is a medical device manufactured by Aok Tooling Limited. It received FDA 510(k) clearance on 2020-09-04 under approval number K201517. 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 Plain Surgical Mask?

Plain Surgical Mask is a medical device that received FDA 510(k) clearance on 2020-09-04. It is manufactured by Aok Tooling Limited. The 510(k) number is K201517.

When was Plain Surgical Mask approved by the FDA?

Plain Surgical Mask received FDA 510(k) clearance on 2020-09-04, under approval number K201517.

What company makes Plain Surgical Mask?

Plain Surgical Mask is manufactured by Aok Tooling Limited.

What is the FDA product code for Plain Surgical Mask?

The FDA product code for Plain Surgical Mask is FXX.

Other Devices by Aok Tooling Limited

K211956039 Surgical Face 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.