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FDA 510(k)

Disposable Surgical Gown UM-148

K-Number: K221717 · 2022-09-20

ApplicantUnimax Medical Products Co., Ltd.
Decision Date2022-09-20
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Surgical Gown UM-148 is a medical device manufactured by Unimax Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-09-20 under approval number K221717. 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 Gown UM-148?

Disposable Surgical Gown UM-148 is a medical device that received FDA 510(k) clearance on 2022-09-20. It is manufactured by Unimax Medical Products Co., Ltd.. The 510(k) number is K221717.

When was Disposable Surgical Gown UM-148 approved by the FDA?

Disposable Surgical Gown UM-148 received FDA 510(k) clearance on 2022-09-20, under approval number K221717.

What company makes Disposable Surgical Gown UM-148?

Disposable Surgical Gown UM-148 is manufactured by Unimax Medical Products Co., Ltd..

What is the FDA product code for Disposable Surgical Gown UM-148?

The FDA product code for Disposable Surgical Gown UM-148 is FYA.

Other Devices by Unimax Medical Products Co., Ltd.

K220749Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP

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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