KME · Class I · 21 CFR 880.6060

FDA Product Code KME: Bedding, Disposable, Medical

Leading manufacturers include Sancella, Inc., Kimberly-Clark Corp. and Haz-Med, Inc..

65
Total
65
Cleared
58d
Avg days
1976
Since
65 devices
25–48 of 65
Cleared Mar 17, 1987
PAD, BED LINEN PROTECTIVE
K870925
Quality Disposables, Inc.
General Hospital · 8d
Cleared Mar 13, 1987
DEPEND UNDERPAD
K870522
Kimberly-Clark Corp.
General Hospital · 35d
Cleared Mar 02, 1987
THERMAPAD
K864158
Avail-Southwest Division
General Hospital · 130d
Cleared Aug 27, 1986
KIMLON DISPOSABLE BLANKET
K863179
Kimberly-Clark Corp.
General Hospital · 9d
Cleared Jul 02, 1986
SINGLE-USE PATIENT UNDERPAD
K862348
Procter & Gamble Mfg. Co.
General Hospital · 12d
Cleared Feb 19, 1986
REFLECTIVE BLANKET
K860066
O.R. Concepts, Inc.
General Hospital · 44d
Cleared Nov 08, 1985
ALPHA CHUCK
K853970
Rocky Mountain Medical Corp.
General Hospital · 43d
Cleared Oct 16, 1985
ATTENDS DISPOS. UNDERPAD
K853880
Procter & Gamble Mfg. Co.
General Hospital · 28d
Cleared Apr 19, 1985
MEDICAL, DISPOSABLE BEDDING
K850067
East Texas Lighthouse For the Blind
General Hospital · 101d
Cleared Mar 21, 1985
PAD, PRE-OPERATIVE PREPARATION
K850811
East Texas Lighthouse For the Blind
General Hospital · 21d
Cleared Mar 12, 1985
SHAVE PREP TRAY
K850544
Packaging Technologies, Inc.
General Hospital · 28d
Cleared Dec 04, 1984
SHAVE PREP KITS
K842989
Biological & Environmental Control Laboratories
General Hospital · 127d
Cleared Dec 04, 1984
WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT
K844196
Biological & Environmental Control Laboratories
General Hospital · 35d
Cleared Oct 24, 1984
DISPOSABLE PATIENT BLANKET
K843038
Anago, Inc.
General Hospital · 83d
Cleared Sep 07, 1984
MOLINEA UNDERPADS
K843402
Paul Hartmann Corp.
General Hospital · 8d
Cleared Aug 01, 1984
PILLOW W/STAPHCHEK TICKING
K842335
Monterey Mills, Inc.
General Hospital · 49d
Cleared Jul 13, 1984
DISPOSABLE PILLOW
K842336
Monterey Mills, Inc.
General Hospital · 30d
Cleared Feb 13, 1984
PILLOW COVER, ANTI-MICROBIAL
K832486
American Threshold Industries, Inc.
General Hospital · 203d
Cleared Feb 13, 1984
DRAW SHEET, ANTI-MICROBIAL
K832487
American Threshold Industries, Inc.
General Hospital · 203d
Cleared Sep 30, 1982
SUPER DONUT
K822650
Alimed, Inc.
General Hospital · 28d
Cleared Jul 02, 1982
BARRIER BURN SHEET
K821835
Uhi Corp.
General Hospital · 10d
Cleared Mar 18, 1982
3M THINSULATE DISPOSABLE HOSPITAL BED
K820582
3M Company
General Hospital · 14d
Cleared Jan 05, 1982
NON-ABSORBENT TOWELS
K813519
Cunningham Woodland, Inc.
General Hospital · 20d
Cleared Nov 27, 1981
PATIENT UNDERPAD
K813263
The Buckeye Cellulose Corp.
General Hospital · 7d