FXX · Product Code · Chrysalis Intelligence

Sponsor	Clearances	Last 12 mo	Most recent
Owens & Minor (O&M) Halyard, Inc.	8	0	2025-05-30
Guangdong Kingfa Sci. & Tech.Co., Ltd.	6	0	2024-07-29
Allmed Medical Products Co., Ltd.	3	0	2021-06-03
Aok Tooling Limited	3	0	2022-07-27
Qinhuangdao Taizhi Medical Technology Co., Ltd.	3	0	2023-02-07
Changzhou Combat Protective Equipment Co., Ltd.	3	0	2021-06-29
Makrite Industries, Inc.	3	1	2026-01-05
Winner Medical Co., Ltd.	3	0	2025-06-18
Nantong Taiweishi Medical Technology Co., Ltd.	2	0	2021-11-13
Qiqihar Hengxin Medical Supplies, Ltd.	2	0	2021-03-15
Gemtier Medical (Shanghai), Inc.	2	0	2021-02-04
Hunan Eexi Technology & Service Co., Ltd.	2	0	2021-03-10
Dukal Corporation	2	0	2021-02-16
Guangzhou Zhengkang Medical Equipment Co.,Ltd	2	0	2022-09-23
Spintech, LLC	2	0	2021-11-14
Wanxinda (Guangzhou) Technology Product Co., Ltd.	2	0	2021-03-10
Ningbo Jingeao Electronics, Inc.	2	0	2021-08-27
Hubei Wanli Protective Products Co., Ltd.	2	0	2022-04-06
Zhejiang Lanhine Medical Products, Ltd.	2	0	2021-09-23
Xiamen Probtain Medical Techology Co., Ltd.	2	0	2021-07-02
Premiumestore, LLC	2	0	2021-06-15
Shandong Shengquan New Material Co., Ltd.	2	0	2020-12-14
Defender Safety, Inc.	2	0	2021-12-06
Han Zhaoqing Sporting Goods Company Limited	2	0	2021-03-03
Homtex, Inc.	2	0	2021-08-19

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
A6403	HCPCS	Gauze, non-impregnated, sterile, pad size more than 16 sq. in. less than or equal to 48 sq. in., without adhesive border, each dressing ✓ CMS-verified description	High	Standard HCPCS code for surgical masks

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-03-18	K251967	O&M Halyard, Inc.	HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor
2026-03-03	K252534	Zhejiang Hangkang Medical Equipment Co., Ltd.	Surgical Face Mask (Ear mount)
2026-02-19	K253398	Efofex, Inc.	Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
2026-01-12	K252830	Beatles Medical Supplies (Xiantao) Co., Ltd.	Disposable Surgical Face Mask (3P00B, C2900)
2026-01-05	K252650	Makrite Industries, Inc.	Disposable Medical Face Mask
2025-12-22	K243342	Kp Trading Co., Ltd.	KP Protective Face Mask
2025-12-11	K252941	O&M Halyard, Inc.	HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
2025-11-04	K252964	Primed Medical Products, Inc.	PRIMED Surgical and Procedure Masks
2025-09-17	K251902	Vitacore Industries, Inc.	Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)
2025-06-18	K250082	Winner Medical Co., Ltd.	Procedure mask/Surgical mask/Face mask
2025-05-30	K243010	Owens & Minor (O&M) Halyard, Inc.	Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce
2024-11-12	K242502	Supermax Healthcare Canada Supermax Medical	Aurelia Surgical Mask ASTM Level-3 (2130)
2024-10-18	K240916	Xiantao Daoqi Plastic Co., Ltd.	Surgical Face Mask (Tie on/ Ear loops)
2024-08-26	K240286	Primed Medical Products, Inc.	PRIMED Surgical Masks and PRIMED Procedure Masks
2024-07-29	K233723	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask
2024-07-02	K232824	Owens & Minor (O&M) Halyard, Inc.	FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)
2024-07-01	K232777	Owens & Minor (O&M) Halyard, Inc.	FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)
2024-06-21	K232807	Owens & Minor (O&M) Halyard, Inc.	Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)
2024-06-14	K232812	Owens & Minor (O&M) Halyard, Inc.	Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)
2024-06-07	K232806	Owens & Minor (O&M) Halyard, Inc.	HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)
2024-06-06	K232968	Golden Grande Corp.	Grande Medical Masks, Model SF-600
2024-06-04	K232820	Owens & Minor (O&M) Halyard, Inc.	HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)
2024-04-18	K240258	Makrite Industries, Inc.	Disposable Medical Face Mask (M643BE)
2024-04-02	K232112	R&G Seguridad E Higiene Industrial S.A.C.	R&G Surgical Mask
2024-03-19	K231719	Azur Medical Company, Inc.	Medical Surgical Mask

FXX · Unclassified

Clearance volume by quarter

Top sponsors in this product code

Likely billing codes (AI-inferred · verify with billing)

Most recent 510(k) clearances