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FDA 510(k)

Dong Hai Xiang Surgical Mask

K-Number: K212203 · 2022-04-07

ApplicantTaizhou Donghaixiang Protective Equipment Co., Ltd.
Decision Date2022-04-07
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dong Hai Xiang Surgical Mask is a medical device manufactured by Taizhou Donghaixiang Protective Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-04-07 under approval number K212203. 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 Dong Hai Xiang Surgical Mask?

Dong Hai Xiang Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-04-07. It is manufactured by Taizhou Donghaixiang Protective Equipment Co., Ltd.. The 510(k) number is K212203.

When was Dong Hai Xiang Surgical Mask approved by the FDA?

Dong Hai Xiang Surgical Mask received FDA 510(k) clearance on 2022-04-07, under approval number K212203.

What company makes Dong Hai Xiang Surgical Mask?

Dong Hai Xiang Surgical Mask is manufactured by Taizhou Donghaixiang Protective Equipment Co., Ltd..

What is the FDA product code for Dong Hai Xiang Surgical Mask?

The FDA product code for Dong Hai Xiang Surgical Mask is FXX.

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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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