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FDA 510(k)

Disposable Medical Face Mask

K-Number: K202628 · 2021-03-19

Decision Date2021-03-19
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Face Mask is a medical device manufactured by Qinghai Zhong Dao Win-Win Medical Protective Equipment Co.,. It received FDA 510(k) clearance on 2021-03-19 under approval number K202628. 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 Medical Face Mask?

Disposable Medical Face Mask is a medical device that received FDA 510(k) clearance on 2021-03-19. It is manufactured by Qinghai Zhong Dao Win-Win Medical Protective Equipment Co.,. The 510(k) number is K202628.

When was Disposable Medical Face Mask approved by the FDA?

Disposable Medical Face Mask received FDA 510(k) clearance on 2021-03-19, under approval number K202628.

What company makes Disposable Medical Face Mask?

Disposable Medical Face Mask is manufactured by Qinghai Zhong Dao Win-Win Medical Protective Equipment Co.,.

What is the FDA product code for Disposable Medical Face Mask?

The FDA product code for Disposable Medical Face Mask is FXX.

Related Clinical Trials

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.