510(k) K202697
- Device
- 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.
- 510(k) number
- K202697
- Product code
- FXX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-05-13
- Date received
- 2020-09-16
- Regulation
- 878.4040
- Classification name
- Mask, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Benjamin Webb
- Address
- 1772 N. Andy Griffith Pkwy. Mount Airy NC US 27030 27030
FDA Registration Numbers#
- 1051614
- 3010363542
- 2029234
- 3016667418
- 3030067857
- 3004361903
- 3006425876
- 3016680688
- 3016635391
- 3013503815
- 3007048057
- 3004111573
- 3043226252
- 3044026004
- 3015960676
- 9681151
- 3016872428
- 3015060216
- 3007046497
- 3029802606
- 3012187973
- 3011545608
- 1423625
- 3006942307
- 3017180923
- 9613778
- 3016968725
- 3004105221
- 3007942528
- 3005022483
- 3008107579
- 3007479164
- 3030582179
- 3008191254
- 3004491689
- 3016426842
- 1929938
- 3017405979
- 3043051314
- 3006891803
- 3005142514
- 1043214
- 3011547453
- 3012711490
- 3024088964
- 3012354669
- 3012268821
- 3044819802
- 3006847952
- 1423537
- 3018116884
- 3008240985
- 9615909
- 3004704697
- 3003348807
- 3015136704
- 3008489813
- 1054241
- 3006973666
- 3018609298
- 9614747
- 3017194442
- 3010141571
- 3016753714
- 3005083505
- 3017171460
- 3006582165
- 3012494290
- 3009963993
- 3031582449
- 1530671
- 3008559312
- 3006113314
- 3009526454
- 3045062172
- 3016649599
- 3013298431
- 2437780
- 3006798117
- 3008384335
Source Documents#
Other 510(k) Records For Product Code FXX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251967 | 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 | O&M Halyard, Inc. | 2026-03-18 |
| K252534 | Surgical Face Mask (Ear mount) | Zhejiang Hangkang Medical Equipment Co., Ltd. | 2026-03-03 |
| K253398 | Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) | Efofex, Inc. | 2026-02-19 |
| K252830 | Disposable Surgical Face Mask (3P00B, C2900) | Beatles Medical Supplies (Xiantao) Co., Ltd. | 2026-01-12 |
| K252650 | Disposable Medical Face Mask | Makrite Industries, Inc. | 2026-01-05 |
| K243342 | KP Protective Face Mask | Kp Trading Co., Ltd. | 2025-12-22 |
| K252941 | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops | O&M Halyard, Inc. | 2025-12-11 |
| K252964 | PRIMED Surgical and Procedure Masks | Primed Medical Products, Inc. | 2025-11-04 |
| K251902 | Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) | Vitacore Industries, Inc. | 2025-09-17 |
| K250082 | Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. | 2025-06-18 |
| K243010 | 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 | Owens & Minor (O&M) Halyard, Inc. | 2025-05-30 |
| K242502 | Aurelia Surgical Mask ASTM Level-3 (2130) | Supermax Healthcare Canada – Supermax Medical | 2024-11-12 |
| K240916 | Surgical Face Mask (Tie on/ Ear loops) | Xiantao Daoqi Plastic Co., Ltd. | 2024-10-18 |
| K240286 | PRIMED Surgical Masks and PRIMED Procedure Masks | Primed Medical Products, Inc. | 2024-08-26 |
| K233723 | Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2024-07-29 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases