510(k) K202463
- Device
- Disposable Surgical Mask
- Applicant
- Unisources Group LLC
- 510(k) number
- K202463
- Product code
- FXX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-09-18
- Date received
- 2020-08-27
- 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
- Yes
Applicant Contact#
- Contact
- Henry Shen
- Address
- 7460 NW 52nd St. Miami FL US 33166 33166
FDA Registration Numbers#
- 3003829571
- 2648727
- 3016426851
- 1320894
- 3010864832
- 3016680721
- 3017597597
- 2433012
- 3030067857
- 9710583
- 3007479164
- 3015633688
- 2431224
- 3008887731
- 3016667418
- 3005246939
- 3004995451
- 3027977504
- 3010141571
- 3004962765
- 2024980
- 3030187570
- 1043214
- 3008107579
- 1530671
- 3004201548
- 3020491541
- 3008808082
- 9614306
- 3008808560
- 3005142514
- 3018020588
- 3016734135
- 3008386507
- 3016452400
- 2424472
- 2939935
- 9680409
- 3004111573
- 8022899
- 3017952635
- 3014312726
- 3045816954
- 3003610374
- 3036622014
- 3006540014
- 1929938
- 3004753358
- 3009104075
- 9681151
- 3013428737
- 3015060216
- 3043650518
- 3044819802
- 3008770655
- 3003495693
- 1420054
- 3012268821
- 3004513970
- 3017910185
- 3016096058
- 3006798117
- 3010374972
- 9616433
- 3044688593
- 3003230618
- 3009488612
- 3010363542
- 3016746332
- 3030419987
- 3016884033
- 3018514354
- 3006113314
- 3004158259
- 3016753714
- 3007053183
- 3002813051
- 3016247944
- 3021486363
- 3014198412
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