FDA 510(k)

Medical Mask

K-Number: K210020 · 2021-04-28

Decision Date2021-04-28

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Medical Mask is a medical device manufactured by Zhende Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-04-28 under approval number K210020. 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 Medical Mask?

Medical Mask is a medical device that received FDA 510(k) clearance on 2021-04-28. It is manufactured by Zhende Medical Co., Ltd.. The 510(k) number is K210020.

When was Medical Mask approved by the FDA?

Medical Mask received FDA 510(k) clearance on 2021-04-28, under approval number K210020.

What company makes Medical Mask?

Medical Mask is manufactured by Zhende Medical Co., Ltd..

What is the FDA product code for Medical Mask?

The FDA product code for Medical Mask is FXX.

Other Devices by Zhende Medical Co., Ltd.

K201729Medical Mask

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.