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FDA 510(k)

Surgical Gown (40083)

K-Number: K233183 · 2024-02-01

ApplicantAmmex-Weida (Hubei) Health and Safety Products Co., Ltd.
Decision Date2024-02-01
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Gown (40083) is a medical device manufactured by Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.. It received FDA 510(k) clearance on 2024-02-01 under approval number K233183. 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 Surgical Gown (40083)?

Surgical Gown (40083) is a medical device that received FDA 510(k) clearance on 2024-02-01. It is manufactured by Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.. The 510(k) number is K233183.

When was Surgical Gown (40083) approved by the FDA?

Surgical Gown (40083) received FDA 510(k) clearance on 2024-02-01, under approval number K233183.

What company makes Surgical Gown (40083)?

Surgical Gown (40083) is manufactured by Ammex-Weida (Hubei) Health and Safety Products Co., Ltd..

What is the FDA product code for Surgical Gown (40083)?

The FDA product code for Surgical Gown (40083) is FYA.

Other Devices by Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.

K211062Medical Face Mask

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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