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FDA 510(k)

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

K-Number: K223401 · 2023-03-07

ApplicantXiamen Probtain Medical Techology Co., Ltd.
Decision Date2023-03-07
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Surgical 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 2023-03-07 under approval number K223401. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)?

Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) is a medical device that received FDA 510(k) clearance on 2023-03-07. It is manufactured by Xiamen Probtain Medical Techology Co., Ltd.. The 510(k) number is K223401.

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

Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) received FDA 510(k) clearance on 2023-03-07, under approval number K223401.

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

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

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

The FDA product code for Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) is FYA.

Related Clinical Trials

NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING

Other Devices by Xiamen Probtain Medical Techology Co., Ltd.

K201893Disposable Surgical Mask K202954Disposable Surgical Mask K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)

Related Devices (Code: FYA)

K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500Gri Medical & Electrical Technology Co., Ltd. K150598Blockade Surgical GownMedline Industries, Inc. K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. K172445RoyalGuard Surgical Gown, i600, BreathableGri Medical & Electrical Technology Co., Ltd. K170762Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC K162930Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, Inc.

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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