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FDA 510(k)

Medical Face Mask

K-Number: K202331 · 2021-02-02

ApplicantGemtier Medical (Shanghai), Inc.
Decision Date2021-02-02
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Face Mask is a medical device manufactured by Gemtier Medical (Shanghai), Inc.. It received FDA 510(k) clearance on 2021-02-02 under approval number K202331. 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?

Medical Face Mask is a medical device that received FDA 510(k) clearance on 2021-02-02. It is manufactured by Gemtier Medical (Shanghai), Inc.. The 510(k) number is K202331.

When was Medical Face Mask approved by the FDA?

Medical Face Mask received FDA 510(k) clearance on 2021-02-02, under approval number K202331.

What company makes Medical Face Mask?

Medical Face Mask is manufactured by Gemtier Medical (Shanghai), Inc..

What is the FDA product code for Medical Face Mask?

The FDA product code for Medical Face Mask is FXX.

Other Devices by Gemtier Medical (Shanghai), Inc.

K170276Safety Blood Collection Device for Single Use K192679Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use K202493Medical Face Mask K212652Sterile Syringe with Fixed Safety Needle for Single Use

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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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