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FDA 510(k)

Disposable Face Mask

K-Number: K202905 · 2021-03-26

Decision Date2021-03-26
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Face Mask is a medical device manufactured by Jiangsu Excellence Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2021-03-26 under approval number K202905. 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 2021-03-26. It is manufactured by Jiangsu Excellence Medical Supplies Co., Ltd.. The 510(k) number is K202905.

When was Disposable Face Mask approved by the FDA?

Disposable Face Mask received FDA 510(k) clearance on 2021-03-26, under approval number K202905.

What company makes Disposable Face Mask?

Disposable Face Mask is manufactured by Jiangsu Excellence Medical Supplies 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 Jiangsu Excellence Medical Supplies Co., Ltd.

Related Devices (Code: FXX)

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.