FDA 510(k)

Medical Face Mask

K-Number: K212471 · 2021-11-04

Decision Date2021-11-04

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Medical Face Mask is a medical device manufactured by Haian Medigauze Co., Ltd.. It received FDA 510(k) clearance on 2021-11-04 under approval number K212471. 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 2021-11-04. It is manufactured by Haian Medigauze Co., Ltd.. The 510(k) number is K212471.

When was Medical Face Mask approved by the FDA?

Medical Face Mask received FDA 510(k) clearance on 2021-11-04, under approval number K212471.

What company makes Medical Face Mask?

Medical Face Mask is manufactured by Haian Medigauze Co., Ltd..

What is the FDA product code for Medical Face Mask?

The FDA product code for Medical Face Mask is FXX.

Related Devices (Code: FXX)

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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.