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FDA 510(k)

Disposable Surgical Gown Rk-3011C

K-Number: K211060 · 2022-10-28

ApplicantXiantao Rhycom Non-Woven Products Co., Ltd.
Decision Date2022-10-28
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Surgical Gown Rk-3011C is a medical device manufactured by Xiantao Rhycom Non-Woven Products Co., Ltd.. It received FDA 510(k) clearance on 2022-10-28 under approval number K211060. 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 Rk-3011C?

Disposable Surgical Gown Rk-3011C is a medical device that received FDA 510(k) clearance on 2022-10-28. It is manufactured by Xiantao Rhycom Non-Woven Products Co., Ltd.. The 510(k) number is K211060.

When was Disposable Surgical Gown Rk-3011C approved by the FDA?

Disposable Surgical Gown Rk-3011C received FDA 510(k) clearance on 2022-10-28, under approval number K211060.

What company makes Disposable Surgical Gown Rk-3011C?

Disposable Surgical Gown Rk-3011C is manufactured by Xiantao Rhycom Non-Woven Products Co., Ltd..

What is the FDA product code for Disposable Surgical Gown Rk-3011C?

The FDA product code for Disposable Surgical Gown Rk-3011C 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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