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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 a medical device manufactured by Xiamen Probtain Medical Techology Co., Ltd.. It received FDA 510(k) clearance on 2023-01-04 under approval 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. It is manufactured by Xiamen Probtain Medical Techology Co., Ltd.. The 510(k) number is K223411.

When was Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) approved by the FDA?

Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) received FDA 510(k) clearance on 2023-01-04, under approval number K223411.

What company makes Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)?

Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) is manufactured by Xiamen Probtain Medical Techology Co., Ltd..

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 Devices by Xiamen Probtain Medical Techology Co., Ltd.

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

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Official Source

View on FDA Database →

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

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