Surgical Gown

FDA 510(k) K211809 · Wuhan Dymex Healthcare Co., Ltd.

Substantially Equivalent

510(k) numberK211809

Submission

Device name
Surgical Gown
Applicant
Wuhan Dymex Healthcare Co., Ltd.
Wuhan, CN
Received
June 11, 2021
Decision date
October 18, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

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

Other 510(k)s with product code FYA

510(k)DeviceApplicantDecision
K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns…FYA · Traditional Principle & Will Co., Ltd.08/26/2026SE
K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)FYA · Traditional Yadu Medical (Henan) Co., Ltd.08/07/2026SE
K261949NYES Tuff Cuff L3 Disposable GownsFYA · Special New York Embroidery Studio07/10/2026SE
K252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)FYA · Traditional New York Embroidery Studio (NYES)06/04/2026SE
K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)FYA · Traditional Hindernis DE Mexico, S.A.P.I. DE C.V.05/12/2026SE
K253243Cardinal Health™ Poly Reinforced Surgical GownFYA · Abbreviated Cardinal Health 200, LLC04/28/2026SE
K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)…FYA · Traditional Hubei Xinxin Non-Woven Co., Ltd.04/20/2026SE
K251860Copioumed AAMI 3 Surgical GownFYA · Traditional Copioumed International, Inc.02/26/2026SE
K252301Henan Yadu Level 4 Surgical Gowns (Reinforced)FYA · Traditional Yadu Medical (Henan) Co., Ltd.02/04/2026SE
K250564Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)FYA · Traditional Yadu Medical (Henan) Co., Ltd.12/03/2025SE

More from Yadu Medical (Henan) Co., Ltd.

510(k)DeviceDecision
K220528Surgical Isolation Cover GownFYC · Traditional 06/10/2022SE
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 Gown cleared by the FDA?

Surgical Gown (K211809) received a 510(k) decision of Substantially Equivalent on October 18, 2021, 129 days after the submission was received.

What is the product code of K211809?

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