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#
- 1423537
- 3016685880
- 3003674698
- 3017425988
- 3031841433
- 3010147274
- 3008770063
- 3008311433
- 3015997711
- 3005030944
- 3005599545
- 3012187973
- 3016884033
- 2433012
- 1054241
- 3017229009
- 3008770655
- 3016452400
- 3005558160
- 3008912871
- 3019848304
- 9611959
- 9680284
- 3021286079
- 3006123105
- 1422598
- 2424472
- 3036622014
- 3017949824
- 3008386507
- 3018609298
- 3010864832
- 3014198412
- 3041276890
- 3035744034
- 3008489813
- 1061124
- 3006942545
- 3020755815
- 3021374000
- 3027517726
- 3015967359
- 3015960676
- 3017171460
- 3009104075
- 9710583
- 3011050560
- 3010598169
- 3017235663
- 3012104670
- 3017910185
- 3008808560
- 3008887731
- 3007966889
- 3015136704
- 3029802606
- 2183301
- 3008384335
- 3008559312
- 3006113314
- 3009488612
- 3042366009
- 3017421555
- 3017952635
- 3003120666
- 1720499
- 3016759113
- 3012502601
- 3006891803
- 3002661124
- 3007407626
- 3014683120
- 9616875
- 2245574
- 3012421607
- 9680887
- 3007942528
- 3007392007
- 3015060216
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