510(k) K213406
- Device
- Savvy Mask - Level 3 Surgical Face Mask
- Applicant
- Texas MedPlast LLC
- 510(k) number
- K213406
- Product code
- FXX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-11-18
- Date received
- 2021-10-19
- 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
- Diego Olmos
- Address
- 6630 Roxburgh Dr. #171 Houston TX US 77041 77041
FDA Registration Numbers#
- 3017168988
- 9615270
- 3009963993
- 3013298431
- 3013735189
- 3015960676
- 3006891803
- 3004425647
- 3011050560
- 3007307589
- 3044026004
- 3011545608
- 3021450335
- 3008048818
- 1319639
- 2183301
- 3010147274
- 3030419987
- 3009526454
- 3008559312
- 3016680721
- 3005599545
- 3006582165
- 3012314549
- 2029234
- 3016759113
- 3044819802
- 3004995451
- 3016968725
- 3012104670
- 3007838093
- 3011547453
- 3004105221
- 3007048057
- 3009307523
- 8022899
- 2022409
- 3007966889
- 9611959
- 3002661124
- 9680409
- 3010363542
- 3010131137
- 3014683120
- 9680222
- 3016966810
- 3016635391
- 3027517726
- 3031582449
- 3004753358
- 3011707784
- 3016685880
- 3016667418
- 3030187570
- 2110898
- 3027977504
- 3014142845
- 1417592
- 3006540014
- 3012852163
- 8030607
- 2433825
- 3017910185
- 3031841433
- 3006425876
- 3012421607
- 1061124
- 3004513970
- 3005558160
- 9614598
- 1055236
- 3017952635
- 3030172764
- 2518423
- 3006973666
- 3015009203
- 3004111573
- 3004704697
- 3006665149
- 9680887
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 |
| K233723 | Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2024-07-29 |
| K232824 | FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) | Owens & Minor (O&M) Halyard, Inc. | 2024-07-02 |
Legacy Summary#
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FDA Review#
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