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FDA 510(k)

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500

K-Number: K162442 · 2016-12-12

ApplicantGri Medical & Electrical Technology Co., Ltd.
Decision Date2016-12-12
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 is a medical device manufactured by Gri Medical & Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-12-12 under approval number K162442. 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 Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500?

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 is a medical device that received FDA 510(k) clearance on 2016-12-12. It is manufactured by Gri Medical & Electrical Technology Co., Ltd.. The 510(k) number is K162442.

When was ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 approved by the FDA?

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 received FDA 510(k) clearance on 2016-12-12, under approval number K162442.

What company makes ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500?

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 is manufactured by Gri Medical & Electrical Technology Co., Ltd..

What is the FDA product code for ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500?

The FDA product code for ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 is FYA.

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

K172445RoyalGuard Surgical Gown, i600, Breathable K163191ComfortGuard Surgical Gown, i600, Film Reinforced

Related Devices (Code: FYA)

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. 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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