Atlas FDA

United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask

FDA 510(k) clearance K202697 · decided 2021-05-13

Clearance details

K-number
K202697
Device name
United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask
Applicant
United Sewing Automation, Inc.
Decision
Substantially Equivalent
Date received
2020-09-16
Decision date
2021-05-13
Days to decision
239 days
Clearance type
Abbreviated
Product code
FXX
Device class
2
Regulation number
878.4040
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Mount Airy, NC, US
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.