FDA 510(k)

Disposable Surgical Gown Rk-3011C

Numéro K : K211060 · 2022-10-28

DemandeurXiantao Rhycom Non-Woven Products Co., Ltd.

Date de décision2022-10-28

Code produitFYA

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Disposable Surgical Gown Rk-3011C is the device name listed in this FDA 510(k) record. The listed applicant is Xiantao Rhycom Non-Woven Products Co., Ltd.. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K211060. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Xiantao Rhycom Non-Woven Products Co., Ltd.. The 510(k) number is K211060.

When did Disposable Surgical Gown Rk-3011C receive FDA 510(k) clearance?

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

Who is the listed applicant for Disposable Surgical Gown Rk-3011C?

The FDA 510(k) record lists Xiantao Rhycom Non-Woven Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Essais cliniques associés

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Dispositifs connexes (Code : FYA)

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Source officielle

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