FDA 510(k)

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

K-Number: K223411 · 2023-01-04

ApplicantXiamen Probtain Medical Techology Co., Ltd.

Decision Date2023-01-04

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 Techology Co., Ltd.. It received FDA 510(k) clearance on 2023-01-04 under 510(k) number K223411. 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 2023-01-04. The listed applicant is Xiamen Probtain Medical Techology Co., Ltd.. The 510(k) number is K223411.

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 2023-01-04, under 510(k) number K223411.

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

The FDA 510(k) record lists Xiamen Probtain Medical Techology 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.

Other records listing Xiamen Probtain Medical Techology Co., Ltd. as applicant

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.

K223401Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)K202954Disposable Surgical Mask K201893Disposable Surgical Mask

Related Devices (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.K212717Paneffort AAMI Level 3 Isolation GownPaneffort, LLC K210414CoverU 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.