FDA 510(k)

Disposable Surgical Isolation Gown

N.º K: K212422 · 2022-04-29

SolicitanteCrown Name Disposable Hygiene Products Fty., Ltd.

Fecha de decisión2022-04-29

Código de productoFYC

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Surgical Isolation Gown is the device name listed in this FDA 510(k) record. The listed applicant is Crown Name Disposable Hygiene Products Fty., Ltd.. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K212422. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Surgical Isolation Gown?

Disposable Surgical Isolation Gown is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Crown Name Disposable Hygiene Products Fty., Ltd.. The 510(k) number is K212422.

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

Disposable Surgical Isolation Gown received FDA 510(k) clearance on 2022-04-29, under 510(k) number K212422.

Who is the listed applicant for Disposable Surgical Isolation Gown?

The FDA 510(k) record lists Crown Name Disposable Hygiene Products Fty., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Otros registros que enlistan a Crown Name Disposable Hygiene Products Fty., Ltd. como solicitante

K203534Surgical face mask (Model: Flat Ear Loop/CN102)

Dispositivos relacionados (Código: 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

Fuente oficial

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