FPY · Sheet, Burn
General Hospital · 21 CFR 880.5180 · Class 1
Overview
| Product Code | FPY |
|---|---|
| Device Name | Sheet, Burn |
| Regulation | 21 CFR 880.5180 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A burn sheet is a device made of a porous material that is wrapped aroung a burn victim to retain body heat, to absorb wound exudate, and to serve as a barrier against contaminants.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K930759 | CP & S STERILE BURN SHEET | Consolidated Products & Services, Inc. | Jan 21, 1994 | SESE |
| K926290 | BURN SHEET | Gam Industries, Inc. | Apr 20, 1993 | SESE |
| K921471 | BURNSHIELD TRAUMA DRESSING | Levtrade Intl. (Pty) , Ltd. | Apr 20, 1993 | SESE |
| K921470 | BURNSHIELD FIRE BLANKET | Levtrade Intl. (Pty) , Ltd. | Apr 20, 1993 | SESE |
| K900443 | BURNS CASUALTY SHEET LIMB WRAP | Pilgrim Medical Services | Jul 3, 1990 | SESE |
| K900442 | BURNS CASUALTY SHEET BURN ROLL | Pilgrim Medical Services | Jul 3, 1990 | SESE |
| K900441 | BURNS CASUALTY SHEET | Pilgrim Medical Services | Jul 3, 1990 | SESE |
| K871740 | LYOSHEET SURGICAL SHEET FOR BURNS | Acme United Corp. | Jun 9, 1987 | SESE |
| K853145 | KENDALL CURITY BURN PAD | The Kendal Co. | Aug 30, 1985 | SN |
| K841898 | FIRST RESPONSE EMERG. MEDICSL - BURNS | Reed Products, Inc. | Aug 14, 1984 | SESE |
| K820994 | ABSORB FURN SHEET | American Convertors Div., American Pharmaseal | May 13, 1982 | SESE |
| K800064 | WATER JEL FIRE BLANKET | Trilling Resources, Ltd. | Mar 25, 1980 | SESE |
| K792433 | TEMPORARY BURN SHEET WITH PERFORATED | American Medical Disposable, Inc. | Dec 20, 1979 | SESE |
| K792432 | TEMPORARY BURN SHEET WITH PERFORATED | American Medical Disposable, Inc. | Dec 20, 1979 | SESE |
| K780418 | BURN DRESSING PAD | The Owenby Co. | Apr 10, 1978 | SESE |
| K760365 | BLANKET, BURN | Winn Hirsch & Assoc. | Aug 11, 1976 | SESE |
| K760210 | BLANKET, WATER-JEL FIRE | American Safety | Aug 11, 1976 | SESE |
Top Applicants
- Pilgrim Medical Services — 3 clearances
- American Medical Disposable, Inc. — 2 clearances
- Levtrade Intl. (Pty) , Ltd. — 2 clearances
- Acme United Corp. — 1 clearance
- American Convertors Div., American Pharmaseal — 1 clearance
