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FDA 510(k)

ComfortGuard Surgical Gown, i600, Film Reinforced

K-Number: K163191 · 2017-02-27

ApplicantGri Medical & Electrical Technology Co., Ltd.
Decision Date2017-02-27
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ComfortGuard Surgical Gown, i600, Film Reinforced is a medical device manufactured by Gri Medical & Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-02-27 under approval number K163191. 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 ComfortGuard Surgical Gown, i600, Film Reinforced?

ComfortGuard Surgical Gown, i600, Film Reinforced is a medical device that received FDA 510(k) clearance on 2017-02-27. It is manufactured by Gri Medical & Electrical Technology Co., Ltd.. The 510(k) number is K163191.

When was ComfortGuard Surgical Gown, i600, Film Reinforced approved by the FDA?

ComfortGuard Surgical Gown, i600, Film Reinforced received FDA 510(k) clearance on 2017-02-27, under approval number K163191.

What company makes ComfortGuard Surgical Gown, i600, Film Reinforced?

ComfortGuard Surgical Gown, i600, Film Reinforced is manufactured by Gri Medical & Electrical Technology Co., Ltd..

What is the FDA product code for ComfortGuard Surgical Gown, i600, Film Reinforced?

The FDA product code for ComfortGuard Surgical Gown, i600, Film Reinforced is FYA.

Other Devices by Gri Medical & Electrical Technology Co., Ltd.

K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 K172445RoyalGuard Surgical Gown, i600, Breathable

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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