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FDA 510(k)

Disposable Surgical Gown

K-Number: K212925 · 2021-12-13

ApplicantHenan Robestain Medical Products Co., Ltd.
Decision Date2021-12-13
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Surgical Gown is a medical device manufactured by Henan Robestain Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-12-13 under approval number K212925. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Surgical Gown?

Disposable Surgical Gown is a medical device that received FDA 510(k) clearance on 2021-12-13. It is manufactured by Henan Robestain Medical Products Co., Ltd.. The 510(k) number is K212925.

When was Disposable Surgical Gown approved by the FDA?

Disposable Surgical Gown received FDA 510(k) clearance on 2021-12-13, under approval number K212925.

What company makes Disposable Surgical Gown?

Disposable Surgical Gown is manufactured by Henan Robestain Medical Products Co., Ltd..

What is the FDA product code for Disposable Surgical Gown?

The FDA product code for Disposable Surgical Gown is FYA.

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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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