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FDA 510(k)

Surgical Isolation Gown

K-Number: K203415 · 2021-05-20

ApplicantYanbian Pacific Textile Co., Ltd.
Decision Date2021-05-20
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Isolation Gown is the device name listed in this FDA 510(k) record. The listed applicant is Yanbian Pacific Textile Co., Ltd.. It received FDA 510(k) clearance on 2021-05-20 under 510(k) number K203415. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surgical Isolation Gown?

Surgical Isolation Gown is a medical device that received FDA 510(k) clearance on 2021-05-20. The listed applicant is Yanbian Pacific Textile Co., Ltd.. The 510(k) number is K203415.

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

Surgical Isolation Gown received FDA 510(k) clearance on 2021-05-20, under 510(k) number K203415.

Who is the listed applicant for Surgical Isolation Gown?

The FDA 510(k) record lists Yanbian Pacific Textile Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Isolation Gown?

The FDA product code for Surgical Isolation Gown is FYC.

Related Devices (Code: FYC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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