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FDA 510(k)

Disposable Face Mask

K-Number: K220191 · 2022-05-24

ApplicantJiujiang Taixin Technology Co., Ltd.
Decision Date2022-05-24
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Face Mask is a medical device manufactured by Jiujiang Taixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-05-24 under approval number K220191. 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 Disposable Face Mask?

Disposable Face Mask is a medical device that received FDA 510(k) clearance on 2022-05-24. It is manufactured by Jiujiang Taixin Technology Co., Ltd.. The 510(k) number is K220191.

When was Disposable Face Mask approved by the FDA?

Disposable Face Mask received FDA 510(k) clearance on 2022-05-24, under approval number K220191.

What company makes Disposable Face Mask?

Disposable Face Mask is manufactured by Jiujiang Taixin Technology Co., Ltd..

What is the FDA product code for Disposable Face Mask?

The FDA product code for Disposable Face Mask is FXX.

Other Devices by Jiujiang Taixin Technology Co., Ltd.

K212919Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

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

View on FDA Database →

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

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