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FDA 510(k)

Disposable Surgical Gown (G4003)

K-Number: K221977 · 2022-10-20

ApplicantXiantao Topmed Nonwoven Protective Products Co., Ltd.
Decision Date2022-10-20
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Surgical Gown (G4003) is a medical device manufactured by Xiantao Topmed Nonwoven Protective Products Co., Ltd.. It received FDA 510(k) clearance on 2022-10-20 under approval number K221977. 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 (G4003)?

Disposable Surgical Gown (G4003) is a medical device that received FDA 510(k) clearance on 2022-10-20. It is manufactured by Xiantao Topmed Nonwoven Protective Products Co., Ltd.. The 510(k) number is K221977.

When was Disposable Surgical Gown (G4003) approved by the FDA?

Disposable Surgical Gown (G4003) received FDA 510(k) clearance on 2022-10-20, under approval number K221977.

What company makes Disposable Surgical Gown (G4003)?

Disposable Surgical Gown (G4003) is manufactured by Xiantao Topmed Nonwoven Protective Products Co., Ltd..

What is the FDA product code for Disposable Surgical Gown (G4003)?

The FDA product code for Disposable Surgical Gown (G4003) is FYA.

Other Devices by Xiantao Topmed Nonwoven Protective Products Co., Ltd.

K221196Disposable Medical Face Mask (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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