510(k) K201380
- Device
- Livocare Surgical Mask
- Applicant
- Andon Health Co., Ltd.
- 510(k) number
- K201380
- Product code
- FXX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-10-07
- Date received
- 2020-05-26
- 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
- Liu Yi
- Address
- # 3 Jin Ping St.,Ya An Rd. Nankai District Tianjin CN 300190 300190
FDA Registration Numbers#
- 9614598
- 3011140825
- 3005327291
- 3016680688
- 3011434305
- 9680887
- 1720499
- 3013428737
- 8030607
- 3017425988
- 3008107579
- 3009526454
- 9616862
- 3021374000
- 3005599545
- 3013525704
- 3008489813
- 9680794
- 3016948452
- 3007307589
- 3009488612
- 3044688593
- 2523320
- 3019848304
- 3003495693
- 3018382937
- 3012628066
- 3009963993
- 3014146451
- 3017910185
- 3010363542
- 3010141571
- 1929938
- 3006665149
- 1320894
- 9616096
- 3016966810
- 2110898
- 3016622475
- 3012421607
- 1423537
- 3008808082
- 3003230618
- 9680357
- 3018020588
- 1000110779
- 3005142514
- 3006123105
- 3017194442
- 3016849443
- 3021286079
- 3013735189
- 3036622014
- 1423625
- 9710583
- 3030419987
- 3005090771
- 1064584
- 9616875
- 2431224
- 3014421917
- 3042366009
- 3017171460
- 2029234
- 3027517726
- 3007615588
- 3017421555
- 3018514354
- 3038718579
- 3006113314
- 3016680721
- 3035744034
- 3045062172
- 3008384335
- 3012187973
- 3007392007
- 2435946
- 3004962765
- 3006973666
- 3016872428
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