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FDA 510(k)

Disposable surgical face mask

K-Number: K220302 · 2022-11-16

Decision Date2022-11-16
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable surgical face mask is a medical device manufactured by Shandong Aida Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-11-16 under approval number K220302. 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 surgical face mask?

Disposable surgical face mask is a medical device that received FDA 510(k) clearance on 2022-11-16. It is manufactured by Shandong Aida Medical Products Co., Ltd.. The 510(k) number is K220302.

When was Disposable surgical face mask approved by the FDA?

Disposable surgical face mask received FDA 510(k) clearance on 2022-11-16, under approval number K220302.

What company makes Disposable surgical face mask?

Disposable surgical face mask is manufactured by Shandong Aida Medical Products Co., Ltd..

What is the FDA product code for Disposable surgical face mask?

The FDA product code for Disposable surgical face mask is FXX.

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.