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FDA 510(k)

RoyalGuard Surgical Gown, i600, Breathable

K-Number: K172445 · 2017-12-08

ApplicantGri Medical & Electrical Technology Co., Ltd.
Decision Date2017-12-08
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RoyalGuard Surgical Gown, i600, Breathable is a medical device manufactured by Gri Medical & Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-12-08 under approval number K172445. 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 RoyalGuard Surgical Gown, i600, Breathable?

RoyalGuard Surgical Gown, i600, Breathable is a medical device that received FDA 510(k) clearance on 2017-12-08. It is manufactured by Gri Medical & Electrical Technology Co., Ltd.. The 510(k) number is K172445.

When was RoyalGuard Surgical Gown, i600, Breathable approved by the FDA?

RoyalGuard Surgical Gown, i600, Breathable received FDA 510(k) clearance on 2017-12-08, under approval number K172445.

What company makes RoyalGuard Surgical Gown, i600, Breathable?

RoyalGuard Surgical Gown, i600, Breathable is manufactured by Gri Medical & Electrical Technology Co., Ltd..

What is the FDA product code for RoyalGuard Surgical Gown, i600, Breathable?

The FDA product code for RoyalGuard Surgical Gown, i600, Breathable is FYA.

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

K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 K163191ComfortGuard Surgical Gown, i600, Film Reinforced

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. K170762Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC K162930Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, Inc. K163191ComfortGuard Surgical Gown, i600, Film ReinforcedGri Medical & Electrical Technology Co., Ltd.

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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