Sheet, Burn
FDA product code FPY · Class I (low risk) · 21 CFR 880.5180 · General Hospital
17510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Pilgrim Medical Services 3
- American Medical Disposable, Inc. 2
- Levtrade Intl. (Pty) , Ltd. 2
- American Safety 1
- Winn Hirsch & Assoc. 1
- The Owenby Co. 1
- Trilling Resources, Ltd. 1
- American Convertors Div., American Pharmaseal 1
- Reed Products, Inc. 1
- The Kendal Co. 1
- Acme United Corp. 1
- Gam Industries, Inc. 1
- Consolidated Products & Services, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K930759 | CP & S Sterile Burn SheetFPY · Traditional | Consolidated Products & Services, Inc. | 01/21/1994SE |
| K926290 | Burn SheetFPY · Traditional | Gam Industries, Inc. | 04/20/1993SE |
| K921471 | Burnshield Trauma DressingFPY · Traditional | Levtrade Intl. (Pty) , Ltd. | 04/20/1993SE |
| K921470 | Burnshield Fire BlanketFPY · Traditional | Levtrade Intl. (Pty) , Ltd. | 04/20/1993SE |
| K900443 | Burns Casualty Sheet Limb WrapFPY · Traditional | Pilgrim Medical Services | 07/03/1990SE |
| K900442 | Burns Casualty Sheet Burn RollFPY · Traditional | Pilgrim Medical Services | 07/03/1990SE |
| K900441 | Burns Casualty SheetFPY · Traditional | Pilgrim Medical Services | 07/03/1990SE |
| K871740 | Lyosheet Surgical Sheet for BurnsFPY · Traditional | Acme United Corp. | 06/09/1987SE |
| K853145 | Kendall Curity Burn PadFPY · Traditional | The Kendal Co. | 08/30/1985SN |
| K841898 | First Response Emerg. Medicsl - BurnsFPY · Traditional | Reed Products, Inc. | 08/14/1984SE |
| K820994 | Absorb Furn SheetFPY · Traditional | American Convertors Div., American Pharmaseal | 05/13/1982SE |
| K800064 | Water Jel Fire BlanketFPY · Traditional | Trilling Resources, Ltd. | 03/25/1980SE |
| K792433 | Temporary Burn Sheet with PerforatedFPY · Traditional | American Medical Disposable, Inc. | 12/20/1979SE |
| K792432 | Temporary Burn Sheet with PerforatedFPY · Traditional | American Medical Disposable, Inc. | 12/20/1979SE |
| K780418 | Burn Dressing PadFPY · Traditional | The Owenby Co. | 04/10/1978SE |
| K760365 | Blanket, BurnFPY · Traditional | Winn Hirsch & Assoc. | 08/11/1976SE |
| K760210 | Blanket, Water-Jel FireFPY · Traditional | American Safety | 08/11/1976SE |
Recalls
| Recall | Product | Firm | 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 | Dukal Corp. | 06/01/2017Terminated |