Procedure Mask, Surgical Mask

FDA 510(k) K202899 · Kenpax International Limited

Substantially Equivalent

510(k) numberK202899

Submission

Device name
Procedure Mask, Surgical Mask
Applicant
Kenpax International Limited
Hong Kong, CN
Received
September 29, 2020
Decision date
May 20, 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
FXX – Mask, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4040
Specialty
General, Plastic Surgery

Other 510(k)s with product code FXX

510(k)DeviceApplicantDecision
K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*…FXX · Traditional O&M Halyard, Inc.03/18/2026SE
K252534Surgical Face Mask (Ear mount)FXX · Traditional Zhejiang Hangkang Medical Equipment Co., Ltd.03/03/2026SE
K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)FXX · Special Efofex, Inc.02/19/2026SE
K252830Disposable Surgical Face Mask (3P00B, C2900)FXX · Traditional Beatles Medical Supplies (Xiantao) Co., Ltd.01/12/2026SE
K252650Disposable Medical Face MaskFXX · Traditional Makrite Industries, Inc.01/05/2026SE
K243342KP Protective Face MaskFXX · Traditional Kp Trading Co., Ltd.12/22/2025SE
K252941HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsFXX · Traditional O&M Halyard, Inc.12/11/2025SE
K252964PRIMED Surgical and Procedure MasksFXX · Traditional Primed Medical Products, Inc.11/04/2025SE
K251902Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield…FXX · Traditional Vitacore Industries, Inc.09/17/2025SE
K250082Procedure mask/Surgical mask/Face maskFXX · Traditional Winner Medical Co., Ltd.06/18/2025SE

More from Winner Medical Co., Ltd.

510(k)DeviceDecision
K222128Protective Gown AAMI Level 4QPC · Traditional 08/08/2023SE
K222151Sterilization WrapFRG · Traditional 03/23/2023SE
K212504Isolation Gown AAMI Level 3FYC · Traditional 11/07/2021SE

Questions and answers

When was Procedure Mask, Surgical Mask cleared by the FDA?

Procedure Mask, Surgical Mask (K202899) received a 510(k) decision of Substantially Equivalent on May 20, 2021, 233 days after the submission was received.

What is the product code of K202899?

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