AOK 95A Medical Mask (20200049)

Q: What is the product code of K220876?

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

FDA 510(k) K220876 · Aok Tooling Limited

Substantially Equivalent

510(k) numberK220876

Submission

Device name: AOK 95A Medical Mask (20200049)
Applicant: Aok Tooling Limited
Cheung Sha Wan, Kowloon, CN
Received: March 25, 2022
Decision date: July 27, 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: 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)	Device	Applicant	Decision
K251967	HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*…FXX · Traditional	O&M Halyard, Inc.	03/18/2026SE
K252534	Surgical Face Mask (Ear mount)FXX · Traditional	Zhejiang Hangkang Medical Equipment Co., Ltd.	03/03/2026SE
K253398	Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)FXX · Special	Efofex, Inc.	02/19/2026SE
K252830	Disposable Surgical Face Mask (3P00B, C2900)FXX · Traditional	Beatles Medical Supplies (Xiantao) Co., Ltd.	01/12/2026SE
K252650	Disposable Medical Face MaskFXX · Traditional	Makrite Industries, Inc.	01/05/2026SE
K243342	KP Protective Face MaskFXX · Traditional	Kp Trading Co., Ltd.	12/22/2025SE
K252941	HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsFXX · Traditional	O&M Halyard, Inc.	12/11/2025SE
K252964	PRIMED Surgical and Procedure MasksFXX · Traditional	Primed Medical Products, Inc.	11/04/2025SE
K251902	Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield…FXX · Traditional	Vitacore Industries, Inc.	09/17/2025SE
K250082	Procedure mask/Surgical mask/Face maskFXX · Traditional	Winner Medical Co., Ltd.	06/18/2025SE

More from Winner Medical Co., Ltd.

510(k)	Device	Decision
K211956	039 Surgical Face MaskFXX · Traditional	11/23/2021SE
K201517	Plain Surgical MaskFXX · Traditional	09/04/2020SE

Questions and answers

When was AOK 95A Medical Mask (20200049) cleared by the FDA?

AOK 95A Medical Mask (20200049) (K220876) received a 510(k) decision of Substantially Equivalent on July 27, 2022, 124 days after the submission was received.

What is the product code of K220876?

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