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FDA 510(k)

AAMI3 Isolation Gown

K-Number: K213832 · 2022-05-16

ApplicantHubei Xinxin Non-Woven Co., Ltd.
Decision Date2022-05-16
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AAMI3 Isolation Gown is a medical device manufactured by Hubei Xinxin Non-Woven Co., Ltd.. It received FDA 510(k) clearance on 2022-05-16 under approval number K213832. 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 AAMI3 Isolation Gown?

AAMI3 Isolation Gown is a medical device that received FDA 510(k) clearance on 2022-05-16. It is manufactured by Hubei Xinxin Non-Woven Co., Ltd.. The 510(k) number is K213832.

When was AAMI3 Isolation Gown approved by the FDA?

AAMI3 Isolation Gown received FDA 510(k) clearance on 2022-05-16, under approval number K213832.

What company makes AAMI3 Isolation Gown?

AAMI3 Isolation Gown is manufactured by Hubei Xinxin Non-Woven Co., Ltd..

What is the FDA product code for AAMI3 Isolation Gown?

The FDA product code for AAMI3 Isolation Gown is FYC.

Other Devices by Hubei Xinxin Non-Woven Co., Ltd.

K214116AAMI4 Isolation Gown K212120Surgical Masks K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)

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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