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#
- 3004962765
- 3004995451
- 3016734135
- 3008386507
- 3004513970
- 1836161
- 3038356900
- 3002661124
- 3005022483
- 3017598017
- 3021486363
- 3011547453
- 3016948452
- 3013006775
- 3010864832
- 3012187973
- 3009104075
- 2083545
- 3005246939
- 3016452400
- 3008770063
- 1064584
- 3010374972
- 3016866909
- 3007046497
- 2523320
- 3004753358
- 2424472
- 3007966889
- 3005558160
- 3042367543
- 2939935
- 1054241
- 3003495693
- 3011707784
- 3014198412
- 9616872
- 3007942528
- 3008912871
- 3011434305
- 3012421607
- 3016968725
- 3014146451
- 3017405979
- 9614598
- 3007134734
- 3014926389
- 2022409
- 1929938
- 3017517827
- 3019848304
- 3007838093
- 3006799943
- 3004425647
- 3016678045
- 3004111573
- 3023228837
- 8030678
- 3016765490
- 3017178899
- 3015820879
- 3008489813
- 3016966810
- 3010409218
- 3008850249
- 1530671
- 3011050560
- 3003829571
- 3021286079
- 3017229009
- 3021274073
- 3006123105
- 1055236
- 3016685880
- 3007088677
- 9680222
- 3010363542
- 3011545608
- 3010147274
- 3042272797
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