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FDA 510(k)

Surgical Gown, Reinforced Surgical Gown

K-Number: K212861 · 2021-12-15

ApplicantWuhan Zonsen Medical Products Co., Ltd.
Decision Date2021-12-15
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Gown, Reinforced Surgical Gown is a medical device manufactured by Wuhan Zonsen Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-12-15 under approval number K212861. 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, Reinforced Surgical Gown?

Surgical Gown, Reinforced Surgical Gown is a medical device that received FDA 510(k) clearance on 2021-12-15. It is manufactured by Wuhan Zonsen Medical Products Co., Ltd.. The 510(k) number is K212861.

When was Surgical Gown, Reinforced Surgical Gown approved by the FDA?

Surgical Gown, Reinforced Surgical Gown received FDA 510(k) clearance on 2021-12-15, under approval number K212861.

What company makes Surgical Gown, Reinforced Surgical Gown?

Surgical Gown, Reinforced Surgical Gown is manufactured by Wuhan Zonsen Medical Products Co., Ltd..

What is the FDA product code for Surgical Gown, Reinforced Surgical Gown?

The FDA product code for Surgical Gown, Reinforced Surgical Gown is FYA.

Other Devices by Wuhan Zonsen Medical Products Co., Ltd.

K202191Surgical Mask K213601Surgical Mask K213688Nitrile Examination Gloves (Model: ZMG1351) K212357Surgical isolation gown K223600Sterilization Wrap

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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