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FDA 510(k)

Disposable Ultra Reinforced Surgical Gown

K-Number: K173847 · 2019-01-16

ApplicantXiantao Rayxin Medical Products Co., Ltd.
Decision Date2019-01-16
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Ultra Reinforced Surgical Gown is a medical device manufactured by Xiantao Rayxin Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2019-01-16 under approval number K173847. 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 Ultra Reinforced Surgical Gown?

Disposable Ultra Reinforced Surgical Gown is a medical device that received FDA 510(k) clearance on 2019-01-16. It is manufactured by Xiantao Rayxin Medical Products Co., Ltd.. The 510(k) number is K173847.

When was Disposable Ultra Reinforced Surgical Gown approved by the FDA?

Disposable Ultra Reinforced Surgical Gown received FDA 510(k) clearance on 2019-01-16, under approval number K173847.

What company makes Disposable Ultra Reinforced Surgical Gown?

Disposable Ultra Reinforced Surgical Gown is manufactured by Xiantao Rayxin Medical Products Co., Ltd..

What is the FDA product code for Disposable Ultra Reinforced Surgical Gown?

The FDA product code for Disposable Ultra Reinforced Surgical Gown is FYA.

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Other Devices by Xiantao Rayxin Medical Products Co., Ltd.

K153496Disposable Surgical Face Mask K222529Surgical 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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