510(k) K210513
- Device
- UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2
- Applicant
- Universal Incorporation
- 510(k) number
- K210513
- Product code
- FXX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-09-29
- Date received
- 2021-02-23
- 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
- Mei-Hui Huang
- Address
- 10f., #372 Linsen N. Rd.,Zhongshan Dist. Taipei City TW 10446 10446
FDA Registration Numbers#
- 3019848304
- 3016714803
- 3016680688
- 3031841433
- 3008808560
- 3016615220
- 3017235663
- 3044819802
- 3006582165
- 3018514354
- 9616875
- 3030067857
- 3017949824
- 3017229009
- 3007307589
- 3012502601
- 3007838093
- 3016654890
- 3007607706
- 3005246939
- 2437780
- 8030607
- 1417592
- 9614598
- 3010363542
- 3004111573
- 3006973666
- 3014198412
- 8030672
- 1530671
- 3005030944
- 3006942545
- 3012494290
- 3007088677
- 3013525704
- 3004753358
- 3008384335
- 3003829571
- 3008912871
- 3016765490
- 1025972
- 3014926389
- 9615909
- 3017498782
- 3010131137
- 3015136704
- 8030678
- 3010154727
- 3027977504
- 3003674698
- 3023228837
- 3045855232
- 3004425647
- 3011862887
- 3004201548
- 3018382937
- 3016864576
- 3005558160
- 9611959
- 3041276890
- 2183301
- 3007942528
- 3011689956
- 3004361903
- 9680357
- 2431224
- 2024980
- 3011089435
- 3014819517
- 3026536498
- 2110898
- 9614306
- 3016685880
- 3010374972
- 3026263452
- 3017421555
- 3004491689
- 3017597597
- 3024088964
- 3044688593
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