KME · Bedding, Disposable, Medical
General Hospital · 21 CFR 880.6060 · Class 1
Overview
| Product Code | KME |
|---|---|
| Device Name | Bedding, Disposable, Medical |
| Regulation | 21 CFR 880.6060 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
Medical disposable bedding is a device intended for medical purposes to be used by one patient for a period of time and then discarded. This generic type of device may include disposable bedsheets, bedpads, pillows and pillowcases, blankets, emergency rescue blankets, or waterproof sheets.
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. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 65)
Showing 20 most recent of 65 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K042145 | READY-HEAT BLANKET | Techtrade, LLC | Sep 17, 2004 | SESE |
| K944953 | OREX MEDICAL BEDDING | Thantex Specialties, Inc. | Dec 2, 1994 | SESE |
| K933636 | DISPOSE-A-SHEET | Belmac Healthcare Corp. | Jan 26, 1994 | SESE |
| K932539 | DOCTOR DOWN --RESCUE WRAP | Three Dog Down | Nov 2, 1993 | SESE |
| K922143 | AMERICAN BURN SHEET | American Silk Sutures, Inc. | Aug 10, 1992 | SESE |
| K915303 | FOIL BABY BUNTING | Gam Industries, Inc. | Feb 20, 1992 | SESE |
| K912257 | CHEM-SLEEVE B | Haz-Med, Inc. | Dec 31, 1991 | SESE |
| K911953 | MEDI GUARD SHEETS/UNDERLAYS | Sancella, Inc. | May 28, 1991 | SESE |
| K911952 | MEDI GUARD UNDERPAD | Sancella, Inc. | May 28, 1991 | SESE |
| K911948 | MEDI GUARD PILLOWCASE | Sancella, Inc. | May 28, 1991 | SESE |
| K911950 | MEDI GUARD DRAPES | Sancella, Inc. | May 21, 1991 | SESE |
| K905003 | BIO-GUARD SHAVE PREP TRAY | Network Medical Systems, Inc. | Dec 28, 1990 | SESK |
| K904274 | RECEIVING BLANKET | Anago, Inc. | Oct 26, 1990 | SESE |
| K901509 | TRAUMA SLEEVE | Haz-Med, Inc. | Sep 12, 1990 | SESE |
| K901629 | CHEM-SLEEVE | Haz-Med, Inc. | Apr 27, 1990 | SESE |
| K900643 | FLUID SOAKERSHIELD | Infection Control Products, Inc. | Apr 25, 1990 | SESE |
| K896043 | MATTRESS COVER FOR MEDICAL PURPOSES | Keystone Veterinary Supplies, Inc. | Jan 10, 1990 | SESE |
| K891986 | MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE | Mark One Healthcare Products | Dec 29, 1989 | SESE |
| K894170 | DEVON DISPOSABLE HEAD POSITIONER COVER | Devon Industries, Inc. | Sep 7, 1989 | SESE |
| K884380 | BED SHEET, PILLOW CASE | Saybrex Intl., Inc. | Nov 8, 1988 | SESE |
Top Applicants
- Sancella, Inc. — 4 clearances
- Anago, Inc. — 3 clearances
- Haz-Med, Inc. — 3 clearances
- Kimberly-Clark Corp. — 3 clearances
- Procter & Gamble Mfg. Co. — 3 clearances
