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FDA 510(k)

Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)

K-Number: K223304 · 2023-02-08

ApplicantXiamen Probtain Medical Technology Co., Ltd.
Decision Date2023-02-08
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Probtain Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-02-08 under 510(k) number K223304. 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 Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)?

Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) is a medical device that received FDA 510(k) clearance on 2023-02-08. The listed applicant is Xiamen Probtain Medical Technology Co., Ltd.. The 510(k) number is K223304.

When did Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) receive FDA 510(k) clearance?

Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) received FDA 510(k) clearance on 2023-02-08, under 510(k) number K223304.

Who is the listed applicant for Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)?

The FDA 510(k) record lists Xiamen Probtain Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)?

The FDA product code for Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) 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.K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd.K212717Paneffort AAMI Level 3 Isolation GownPaneffort, LLCK210414CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo GownMedtecs (Taiwan) Corp.

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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