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FDA 510(k)

Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)

K-Number: K222266 · 2022-09-26

ApplicantJingzhou Haixin Green Cross Medical Products Co., Ltd.
Decision Date2022-09-26
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) is a medical device manufactured by Jingzhou Haixin Green Cross Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-09-26 under approval number K222266. 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 Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)?

Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) is a medical device that received FDA 510(k) clearance on 2022-09-26. It is manufactured by Jingzhou Haixin Green Cross Medical Products Co., Ltd.. The 510(k) number is K222266.

When was Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) approved by the FDA?

Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) received FDA 510(k) clearance on 2022-09-26, under approval number K222266.

What company makes Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)?

Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) is manufactured by Jingzhou Haixin Green Cross Medical Products Co., Ltd..

What is the FDA product code for Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)?

The FDA product code for Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) is FXX.

Other Devices by Jingzhou Haixin Green Cross Medical Products Co., Ltd.

K171535SURGICAL ISOLATION GOWN

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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