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FDA 510(k)

ComfortGuard Surgical Isolation Gown

K-Number: K210131 · 2021-08-26

ApplicantGri-Alleset, Inc.
Decision Date2021-08-26
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ComfortGuard Surgical Isolation Gown is a medical device manufactured by Gri-Alleset, Inc.. It received FDA 510(k) clearance on 2021-08-26 under approval number K210131. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ComfortGuard Surgical Isolation Gown?

ComfortGuard Surgical Isolation Gown is a medical device that received FDA 510(k) clearance on 2021-08-26. It is manufactured by Gri-Alleset, Inc.. The 510(k) number is K210131.

When was ComfortGuard Surgical Isolation Gown approved by the FDA?

ComfortGuard Surgical Isolation Gown received FDA 510(k) clearance on 2021-08-26, under approval number K210131.

What company makes ComfortGuard Surgical Isolation Gown?

ComfortGuard Surgical Isolation Gown is manufactured by Gri-Alleset, Inc..

What is the FDA product code for ComfortGuard Surgical Isolation Gown?

The FDA product code for ComfortGuard Surgical Isolation Gown is FYC.

Other Devices by Gri-Alleset, Inc.

K220917gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler K210860Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 K242664gentleheel® Adult Incision Device

Related Devices (Code: FYC)

K160361PRIMAGARD Isolation Gown (AAMI PB70 Level 3)Primed Medical Products, Inc. K160339Cardinal Health Isolation GownCardinal Health200, LLC K160471Medline Non-Surgical Isolation Gown-Medline Industries, Inc. K171535SURGICAL ISOLATION GOWNJingzhou Haixin Green Cross Medical Products Co., Ltd. K190306AMD Ritmed AssureWear VersaGownAmd Medicom, Inc. K212633Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, BlueString King Lacrosse, LLC

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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