AAMI4 Isolation Gown

FDA 510(k) K214116 · Hubei Xinxin Non-Woven Co., Ltd.

Substantially Equivalent

510(k) numberK214116

Submission

Device name
AAMI4 Isolation Gown
Applicant
Hubei Xinxin Non-Woven Co., Ltd.
Xiantao, CN
Received
December 30, 2021
Decision date
October 11, 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
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
K213832AAMI3 Isolation GownFYC · Traditional Hubei Xinxin Non-Woven Co., Ltd.05/16/2022SE

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

510(k)DeviceDecision
K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)…FYA · Traditional 04/20/2026SE
K213832AAMI3 Isolation GownFYC · Traditional 05/16/2022SE
K212120Surgical MasksFXX · Traditional 01/28/2022SE

Questions and answers

When was AAMI4 Isolation Gown cleared by the FDA?

AAMI4 Isolation Gown (K214116) received a 510(k) decision of Substantially Equivalent on October 11, 2022, 285 days after the submission was received.

What is the product code of K214116?

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