510(k) K070407
- Device
- DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE
- Applicant
- DUKAL CORP.
- 510(k) number
- K070407
- Product code
- FXX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-03-26
- Date received
- 2007-02-12
- 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
- PATRICK J LAMB
- Address
- 5 Plant Ave. Hauppauge NY US 11788 11788
FDA Registration Numbers#
- 3010598169
- 2939935
- 3015633688
- 3004105221
- 3014925393
- 3017450342
- 1530671
- 2183301
- 3004111573
- 3005030944
- 3004995451
- 3008494033
- 3045816954
- 3045062172
- 3004753358
- 3005246939
- 3008311433
- 3021286079
- 3012187973
- 3016968725
- 3015136704
- 3017910185
- 3013428737
- 3002813051
- 1929938
- 3016948452
- 3004513970
- 3017517827
- 3010374972
- 1319639
- 3010864832
- 3016734135
- 3017598017
- 3021450335
- 3006723155
- 3003120666
- 9616862
- 2431224
- 3043650518
- 3017425988
- 3015960676
- 1055236
- 3004361903
- 3009700166
- 3016864576
- 3030582179
- 3004158259
- 9615909
- 3007407626
- 1423537
- 3016654890
- 3017952635
- 2024980
- 3013496867
- 3030419987
- 3014421917
- 3008808082
- 2083545
- 3003674698
- 3006123105
- 3017405979
- 3021486363
- 3016247944
- 9614306
- 3027517726
- 2433825
- 3012104670
- 3003495693
- 3006847952
- 1319130
- 3016680688
- 2022409
- 3007966889
- 3012354669
- 3012761602
- 3008489813
- 9614598
- 3004491689
- 3006798117
- 9710583
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#
summary
FDA Review#
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