510(k) K001951
- Device
- PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306
- Applicant
- PRIMELINE MEDICAL PRODUCTS, INC.
- 510(k) number
- K001951
- Product code
- FXX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-09-08
- Date received
- 2000-06-27
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KATHERINE CO
- Address
- 10707 100th Ave., Suite 300 Edmonton, Alberta CA T5J 3M1 T5J 3M1
FDA Registration Numbers#
- 3006799943
- 3016710511
- 1060680
- 3019848304
- 3016680721
- 3017910185
- 1719330
- 1000110779
- 3014819517
- 3010131137
- 3018382937
- 3021486363
- 3012268821
- 3021374000
- 3006400329
- 3007392007
- 3014925393
- 3021274073
- 2183416
- 3018609298
- 2431224
- 2424472
- 3017450342
- 3015058854
- 3009486864
- 3012761602
- 3008770063
- 3013557562
- 3011547453
- 3030187570
- 8030672
- 3013580507
- 1417592
- 3004962765
- 8030678
- 3006897516
- 2939935
- 3016615220
- 3041276890
- 3030067857
- 3020755815
- 2518423
- 3008494033
- 3006942307
- 3008240985
- 3014142845
- 3006891803
- 2022409
- 3006540014
- 3008887731
- 3012187973
- 3004105221
- 3008107579
- 3015820879
- 3010864832
- 1320894
- 3038356900
- 3008132392
- 3012314549
- 3011390041
- 9615270
- 3043650518
- 3002691626
- 3007607706
- 3014198412
- 3006691703
- 3015140351
- 3007942528
- 3006113262
- 3017171460
- 3038718579
- 3026536498
- 2024980
- 2083545
- 3015967359
- 3008559312
- 3016601021
- 3015136704
- 3013525704
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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