Isolation Gown AAMI Level 3

FDA 510(k) K212504 · Kenpax International Limited

Substantially Equivalent

510(k) numberK212504

Submission

Device name
Isolation Gown AAMI Level 3
Applicant
Kenpax International Limited
Hong Kong, CN
Received
August 9, 2021
Decision date
November 7, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FYC – Gown, Isolation, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4040
Specialty
General, Plastic Surgery

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K230135Copioumed Chemotherapy Isolation GownFYC · Traditional Copioumed International, Inc.10/04/2023SE
K223467Disposable Isolation GownFYC · Traditional Nanning Tecbod Biological Technology Co., Ltd.02/10/2023SE
K223304Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)FYC · Traditional Xiamen Probtain Medical Technology Co., Ltd.02/08/2023SE
K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)FYC · Traditional Xiamen Probtain Medical Techology Co., Ltd.01/04/2023SE
K212717Paneffort AAMI Level 3 Isolation GownFYC · Traditional Paneffort, LLC11/30/2022SE
K210414CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with…FYC · Traditional Medtecs (Taiwan) Corp.10/21/2022SE
K214116AAMI4 Isolation GownFYC · Traditional Hubei Xinxin Non-Woven Co., Ltd.10/11/2022SE
K221027Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))FYC · Traditional Allmed Medical (Hubei) Protective Products Co.…08/12/2022SE
K220528Surgical Isolation Cover GownFYC · Traditional Wuhan Dymex Healthcare Co., Ltd.06/10/2022SE

More from Wuhan Dymex Healthcare Co., Ltd.

510(k)DeviceDecision
K222128Protective Gown AAMI Level 4QPC · Traditional 08/08/2023SE
K222151Sterilization WrapFRG · Traditional 03/23/2023SE
K202899Procedure Mask, Surgical MaskFXX · Traditional 05/20/2021SE

Questions and answers

When was Isolation Gown AAMI Level 3 cleared by the FDA?

Isolation Gown AAMI Level 3 (K212504) received a 510(k) decision of Substantially Equivalent on November 7, 2021, 90 days after the submission was received.

What is the product code of K212504?

The FDA product code is FYC – Gown, Isolation, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.