510(k) K210147
- Device
- Unico High Performance Surgical Mask, Unico High Performance Surgical Mask With Face Shield
- Applicant
- Unicoglobal, Inc.
- 510(k) number
- K210147
- Product code
- FXX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-12-22
- Date received
- 2021-01-21
- Regulation
- 878.4040
- Classification name
- Mask, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Yoonsok Park
- Address
- #904, Woolim Pangyo W-City 9-22, Pangyo-Ro 255bion-Gil Bundang-Gu Seongnam KR 13486 13486
FDA Registration Numbers#
- 3011089435
- 1719330
- 3008048818
- 3008912871
- 3013496867
- 3012628066
- 3006123105
- 1064584
- 3015997711
- 3002691626
- 3021486363
- 3010014065
- 3038219378
- 3007305485
- 3004105221
- 3013503815
- 3006400329
- 3005599545
- 3005090771
- 3015140351
- 3021274073
- 3016753714
- 9680455
- 9681151
- 3013735189
- 2435946
- 1060680
- 3012354669
- 3010155681
- 3043226252
- 3009526454
- 3006665149
- 3010363542
- 3020755815
- 3013525704
- 3017168988
- 3024088964
- 1055236
- 3005327291
- 3014146451
- 3014819517
- 3006113314
- 3011390041
- 3011391433
- 3012314549
- 1423625
- 3021286079
- 3031841433
- 3035744034
- 3009307523
- 3012494290
- 3016680721
- 3042272797
- 3041276890
- 3004995451
- 3005083505
- 3008311433
- 3017425988
- 3017517827
- 3017910185
- 9680222
- 3007392007
- 2433825
- 3003230618
- 3007479164
- 1423537
- 3006897516
- 3008489813
- 3017450342
- 3018514354
- 3008191254
- 9616872
- 1921846
- 3016452400
- 3007407626
- 3010409218
- 3013006775
- 3006942307
- 3011862887
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