Surgical Isolation Cover Gown

FDA 510(k) K220528 · Wuhan Dymex Healthcare Co., Ltd.

Substantially Equivalent

510(k) numberK220528

Submission

Device name
Surgical Isolation Cover Gown
Applicant
Wuhan Dymex Healthcare Co., Ltd.
Wuhan, CN
Received
February 24, 2022
Decision date
June 10, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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

Other 510(k)s with product code FYC

510(k)DeviceApplicantDecision
K232849Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3…FYC · Abbreviated Owens & Minor (O&M) Halyard, Inc.05/16/2024SE
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
K213832AAMI3 Isolation GownFYC · Traditional Hubei Xinxin Non-Woven Co., Ltd.05/16/2022SE

More from Hubei Xinxin Non-Woven Co., Ltd.

510(k)DeviceDecision
K211809Surgical GownFYA · Traditional 10/18/2021SE
K210433Surgical Face Mask (Ear loops and Tie-on)FXX · Traditional 06/07/2021SE
K182515Surgical Face MaskFXX · Traditional 05/27/2019SE

Questions and answers

When was Surgical Isolation Cover Gown cleared by the FDA?

Surgical Isolation Cover Gown (K220528) received a 510(k) decision of Substantially Equivalent on June 10, 2022, 106 days after the submission was received.

What is the product code of K220528?

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