Dukal Corp.
Medical device manufacturer in Ronkonkoma, NY.
20510(k) clearances
0PMA approvals
1recalls
Device types
- EFQ Gauze/Sponge, Internal 4
- FXX Mask, Surgical 4
- FRG Wrap, Sterilization 2
- FPX Strip, Adhesive, Closure, Skin 1
- MGP Dressing, Wound And Burn, Occlusive 1
- MLY Vapocoolant Device 1
- HIB Speculum, Vaginal, Nonmetal 1
- MSH Respirator, Surgical 1
- KKX Drape, Surgical, Antimicrobial 1
- KMJ Lubricant, Patient 1
- FYA Gown, Surgical 1
- OXZ Pediatric/Child Facemask 1
- QPC Gown, Non-Sterile, Non-Isolation, Intended… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252823 | Dukal Crepe Paper Sterilization WrapFRG · Traditional | 05/28/2026SE |
| K233262 | Dukal SMS Sterilization WrapFRG · Traditional | 03/22/2024SE |
| K212464 | Dukal Corporation AAMI Level 4 Open-Back Protective GownQPC · Traditional | 03/30/2022SE |
| K210321 | Dukal Corporation Level 1 Pediatric Face MaskOXZ · Traditional | 03/29/2022SE |
| K203237 | Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown…FYA · Traditional | 03/18/2022SE |
| K201732 | Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3…FXX · Traditional | 02/16/2021SE |
| K201421 | Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2…FXX · Traditional | 02/05/2021SE |
| K113689 | Dukal Lubricating JellyKMJ · Traditional | 05/04/2012SE |
| K083320 | Dukal Surgical Drape; Fenestrated Dukal Surgical DrapeKKX · Traditional | 03/06/2009SE |
| K070692 | Dukal N95PARTICULATE Respirator/Surgical Face MaskMSH · Traditional | 05/30/2007SE |
| K070407 | Dukal Surgical Face Mask Tie, Ear Loop, with Shield Yellow & White; Anti Fog Tie, Loop…FXX · Traditional | 03/26/2007SE |
| K061864 | Dukal Surgical Face Mask Tie-On, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560FXX · Traditional | 09/15/2006SE |
| K020726 | Dukal Disposable Vaginal Speculum, Small, Medium, and LargeHIB · Traditional | 05/15/2002SE |
| K984564 | Ethyl Chloride DispenserMLY · Traditional | 12/02/1999SE |
| K970457 | Dukal Abd Combine PadEFQ · Traditional | 05/08/1997SE |
| K970455 | Dukal Non Adherent DressingEFQ · Traditional | 05/08/1997SE |
| K955476 | Dukal Transparent Wound DressingMGP · Traditional | 01/18/1996SN |
| K940440 | Dukal Non-Woven GauzeEFQ · Traditional | 03/09/1994SE |
| K936095 | Gauze SpongeEFQ · Traditional | 02/02/1994SE |
| K931005 | Dukal Skin Closure StripFPX · Traditional | 07/14/1993SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0233-2018 Class II | BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May…Intact carton revealed presence of shredded burn sheets | 06/01/2017Terminated |