FDA 510(k)

Disposable Surgical Gowns

Numéro K : K210785 · 2021-11-13

DemandeurChongqing Litai Fashion Group Limited Company

Date de décision2021-11-13

Code produitFYC

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Disposable Surgical Gowns is the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Litai Fashion Group Limited Company. It received FDA 510(k) clearance on 2021-11-13 under 510(k) number K210785. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Disposable Surgical Gowns?

Disposable Surgical Gowns is a medical device that received FDA 510(k) clearance on 2021-11-13. The listed applicant is Chongqing Litai Fashion Group Limited Company. The 510(k) number is K210785.

When did Disposable Surgical Gowns receive FDA 510(k) clearance?

Disposable Surgical Gowns received FDA 510(k) clearance on 2021-11-13, under 510(k) number K210785.

Who is the listed applicant for Disposable Surgical Gowns?

The FDA 510(k) record lists Chongqing Litai Fashion Group Limited Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Surgical Gowns?

The FDA product code for Disposable Surgical Gowns is FYC.

Essais cliniques associés

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Dispositifs connexes (Code : FYC)

K232849Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)Owens & Minor (O&M) Halyard, Inc.K230135Copioumed Chemotherapy Isolation GownCopioumed International, Inc.K223467Disposable Isolation GownNanning Tecbod Biological Technology Co., Ltd.K223304Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Technology Co., Ltd.K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd.K212717Paneffort AAMI Level 3 Isolation GownPaneffort, LLC

Source officielle

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