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FDA 510(k)

Protective Face Mask for Medical Use

K-Number: K202358 · 2021-01-29

ApplicantHunan Heng Chang Pharmaceutical Co., Ltd.
Decision Date2021-01-29
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Protective Face Mask for Medical Use is a medical device manufactured by Hunan Heng Chang Pharmaceutical Co., Ltd.. It received FDA 510(k) clearance on 2021-01-29 under approval number K202358. 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 Protective Face Mask for Medical Use?

Protective Face Mask for Medical Use is a medical device that received FDA 510(k) clearance on 2021-01-29. It is manufactured by Hunan Heng Chang Pharmaceutical Co., Ltd.. The 510(k) number is K202358.

When was Protective Face Mask for Medical Use approved by the FDA?

Protective Face Mask for Medical Use received FDA 510(k) clearance on 2021-01-29, under approval number K202358.

What company makes Protective Face Mask for Medical Use?

Protective Face Mask for Medical Use is manufactured by Hunan Heng Chang Pharmaceutical Co., Ltd..

What is the FDA product code for Protective Face Mask for Medical Use?

The FDA product code for Protective Face Mask for Medical Use is FXX.

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Related PubMed Literature

PMID: 30016835 Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel. Final order. Federal register (2018)

Other Devices by Hunan Heng Chang Pharmaceutical Co., Ltd.

K202354Surgical Mask-Model Number CW01

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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