Atlas FDA

Surgical Face Mask

FDA 510(k) clearance K212863 · decided 2022-02-19

Clearance details

K-number
K212863
Device name
Surgical Face Mask
Applicant
Taiwan Comfort Champ Manufacturing Co., Ltd.
Decision
Substantially Equivalent
Date received
2021-09-08
Decision date
2022-02-19
Days to decision
164 days
Clearance type
Traditional
Product code
FXX
Device class
2
Regulation number
878.4040
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Taoyuan City, TW
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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 (K251967)O&M Halyard, Inc.2026-03-18
Surgical Face Mask (Ear mount) (K252534)Zhejiang Hangkang Medical Equipment Co., Ltd.2026-03-03
Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) (K253398)Efofex, Inc.2026-02-19
Disposable Surgical Face Mask (3P00B, C2900) (K252830)Beatles Medical Supplies (Xiantao) Co., Ltd.2026-01-12
Disposable Medical Face Mask (K252650)Makrite Industries, Inc.2026-01-05
KP Protective Face Mask (K243342)Kp Trading Co., Ltd.2025-12-22
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops (K252941)O&M Halyard, Inc.2025-12-11
PRIMED Surgical and Procedure Masks (K252964)Primed Medical Products, Inc.2025-11-04
Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) (K251902)Vitacore Industries, Inc.2025-09-17
Procedure mask/Surgical mask/Face mask (K250082)Winner Medical Co., Ltd.2025-06-18
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 (K243010)Owens & Minor (O&M) Halyard, Inc.2025-05-30
Aurelia Surgical Mask ASTM Level-3 (2130) (K242502)Supermax Healthcare Canada – Supermax Medical2024-11-12

Recalls involving this device

No recalls on record reference this clearance.