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FDA 510(k)

Medical Face Mask (M001)

K-Number: K221273 · 2022-06-28

ApplicantXingyu Medical Tech Co., Ltd.
Decision Date2022-06-28
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Face Mask (M001) is a medical device manufactured by Xingyu Medical Tech Co., Ltd.. It received FDA 510(k) clearance on 2022-06-28 under approval number K221273. 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 Medical Face Mask (M001)?

Medical Face Mask (M001) is a medical device that received FDA 510(k) clearance on 2022-06-28. It is manufactured by Xingyu Medical Tech Co., Ltd.. The 510(k) number is K221273.

When was Medical Face Mask (M001) approved by the FDA?

Medical Face Mask (M001) received FDA 510(k) clearance on 2022-06-28, under approval number K221273.

What company makes Medical Face Mask (M001)?

Medical Face Mask (M001) is manufactured by Xingyu Medical Tech Co., Ltd..

What is the FDA product code for Medical Face Mask (M001)?

The FDA product code for Medical Face Mask (M001) is FXX.

Other Devices by Xingyu Medical Tech Co., Ltd.

K212578Nitrile disposable examination gloves K212735Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) K240629Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl

Related Devices (Code: 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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