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FDA 510(k)

Surgical Isolation Cover Gown

K-Number: K220528 · 2022-06-10

ApplicantWuhan Dymex Healthcare Co., Ltd.
Decision Date2022-06-10
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Isolation Cover Gown is a medical device manufactured by Wuhan Dymex Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2022-06-10 under approval number K220528. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surgical Isolation Cover Gown?

Surgical Isolation Cover Gown is a medical device that received FDA 510(k) clearance on 2022-06-10. It is manufactured by Wuhan Dymex Healthcare Co., Ltd.. The 510(k) number is K220528.

When was Surgical Isolation Cover Gown approved by the FDA?

Surgical Isolation Cover Gown received FDA 510(k) clearance on 2022-06-10, under approval number K220528.

What company makes Surgical Isolation Cover Gown?

Surgical Isolation Cover Gown is manufactured by Wuhan Dymex Healthcare Co., Ltd..

What is the FDA product code for Surgical Isolation Cover Gown?

The FDA product code for Surgical Isolation Cover Gown is FYC.

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Other Devices by Wuhan Dymex Healthcare Co., Ltd.

K182515Surgical Face Mask K211809Surgical Gown K210433Surgical Face Mask (Ear loops and Tie-on)

Related Devices (Code: FYC)

K160361PRIMAGARD Isolation Gown (AAMI PB70 Level 3)Primed Medical Products, Inc. K160339Cardinal Health Isolation GownCardinal Health200, LLC K160471Medline Non-Surgical Isolation Gown-Medline Industries, Inc. K171535SURGICAL ISOLATION GOWNJingzhou Haixin Green Cross Medical Products Co., Ltd. K190306AMD Ritmed AssureWear VersaGownAmd Medicom, Inc. K212633Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, BlueString King Lacrosse, LLC

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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