Product Code: KME FDA class 1 21 CFR 880.6060

Bedding, Disposable, Medical

General Hospital

Disposable Medical Bedding refers to single-use bed linens, pads, or protective covers used in healthcare settings to maintain patient hygiene, absorb fluids, and reduce the risk of cross-contamination between patients. It is classified as FDA Class 1, indicating low risk subject to general controls without premarket clearance required. The product code is KME and it falls under 21 CFR 880.6060 in the General Hospital specialty. This device is GMP exempt.

View on FDA

510(k)s

FEI Numbers

573

Registration Numbers

573

Unique Applicants

Years Active

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Basic Information

Product Code: KME
Device Class: FDA class 1
Regulation Number: 880.6060
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 65 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K042145	READY-HEAT BLANKET	Sep 17, 2004	Substantially Equivalent	Techtrade, LLC
K944953	OREX MEDICAL BEDDING	Dec 02, 1994	Substantially Equivalent	Thantex Specialties, Inc.
K933636	DISPOSE-A-SHEET	Jan 26, 1994	Substantially Equivalent	Belmac Healthcare Corp.
K932539	DOCTOR DOWN --RESCUE WRAP	Nov 02, 1993	Substantially Equivalent	Three Dog Down
K922143	AMERICAN BURN SHEET	Aug 10, 1992	Substantially Equivalent	American Silk Sutures, Inc.
K915303	FOIL BABY BUNTING	Feb 20, 1992	Substantially Equivalent	Gam Industries, Inc.
K912257	CHEM-SLEEVE B	Dec 31, 1991	Substantially Equivalent	Haz-Med, Inc.
K911953	MEDI GUARD SHEETS/UNDERLAYS	May 28, 1991	Substantially Equivalent	Sancella, Inc.
K911952	MEDI GUARD UNDERPAD	May 28, 1991	Substantially Equivalent	Sancella, Inc.
K911948	MEDI GUARD PILLOWCASE	May 28, 1991	Substantially Equivalent	Sancella, Inc.
K911950	MEDI GUARD DRAPES	May 21, 1991	Substantially Equivalent	Sancella, Inc.
K905003	BIO-GUARD SHAVE PREP TRAY	Dec 28, 1990	Unknown	Network Medical Systems, Inc.
K904274	RECEIVING BLANKET	Oct 26, 1990	Substantially Equivalent	Anago, Inc.
K901509	TRAUMA SLEEVE	Sep 12, 1990	Substantially Equivalent	Haz-Med, Inc.
K901629	CHEM-SLEEVE	Apr 27, 1990	Substantially Equivalent	Haz-Med, Inc.
K900643	FLUID SOAKERSHIELD	Apr 25, 1990	Substantially Equivalent	Infection Control Products, Inc.
K896043	MATTRESS COVER FOR MEDICAL PURPOSES	Jan 10, 1990	Substantially Equivalent	Keystone Veterinary Supplies, Inc.
K891986	MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE	Dec 29, 1989	Substantially Equivalent	Mark One Healthcare Products
K894170	DEVON DISPOSABLE HEAD POSITIONER COVER	Sep 07, 1989	Substantially Equivalent	Devon Industries, Inc.
K884380	BED SHEET, PILLOW CASE	Nov 08, 1988	Substantially Equivalent	Saybrex Intl., Inc.
K882332	HEADREST, PATIENT COMFORT	Jul 19, 1988	Substantially Equivalent	Surgic Aid, Inc.
K881969	DRY COMFORT DISPOSABLE UNDERPAD	Jun 07, 1988	Substantially Equivalent	Health Tec, Inc.
K881859	DRIPRIDE DISPOSABLE UNDERPAD	Jun 03, 1988	Substantially Equivalent	Weyerhaeuser Co.
K871725	DRIPRIDE DISPOSABLE UNDERPADS	May 15, 1987	Substantially Equivalent	Weyerhaeuser Co.
K870925	PAD, BED LINEN PROTECTIVE	Mar 17, 1987	Substantially Equivalent	Quality Disposables, Inc.
K870522	DEPEND UNDERPAD	Mar 13, 1987	Substantially Equivalent	Kimberly-Clark Corp.
K864158	THERMAPAD	Mar 02, 1987	Substantially Equivalent	Avail-Southwest Division
K863179	KIMLON DISPOSABLE BLANKET	Aug 27, 1986	Substantially Equivalent	Kimberly-Clark Corp.
K862348	SINGLE-USE PATIENT UNDERPAD	Jul 02, 1986	Substantially Equivalent	Procter & Gamble Mfg. Co.
K860066	REFLECTIVE BLANKET	Feb 19, 1986	Substantially Equivalent	O.R. Concepts, Inc.
K853970	ALPHA CHUCK	Nov 08, 1985	Substantially Equivalent	Rocky Mountain Medical Corp.
K853880	ATTENDS DISPOS. UNDERPAD	Oct 16, 1985	Substantially Equivalent	Procter & Gamble Mfg. Co.
K850067	MEDICAL, DISPOSABLE BEDDING	Apr 19, 1985	Substantially Equivalent	East Texas Lighthouse For the Blind
K850811	PAD, PRE-OPERATIVE PREPARATION	Mar 21, 1985	Substantially Equivalent	East Texas Lighthouse For the Blind
K850544	SHAVE PREP TRAY	Mar 12, 1985	Substantially Equivalent	Packaging Technologies, Inc.
K844196	WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT	Dec 04, 1984	Substantially Equivalent	Biological & Environmental Control Laboratories
K842989	SHAVE PREP KITS	Dec 04, 1984	Substantially Equivalent	Biological & Environmental Control Laboratories
K843038	DISPOSABLE PATIENT BLANKET	Oct 24, 1984	Substantially Equivalent	Anago, Inc.
K843402	MOLINEA UNDERPADS	Sep 07, 1984	Substantially Equivalent	Paul Hartmann Corp.
K842335	PILLOW W/STAPHCHEK TICKING	Aug 01, 1984	Substantially Equivalent	Monterey Mills, Inc.
K842336	DISPOSABLE PILLOW	Jul 13, 1984	Substantially Equivalent	Monterey Mills, Inc.
K832487	DRAW SHEET, ANTI-MICROBIAL	Feb 13, 1984	Substantially Equivalent	American Threshold Industries, Inc.
K832486	PILLOW COVER, ANTI-MICROBIAL	Feb 13, 1984	Substantially Equivalent	American Threshold Industries, Inc.
K822650	SUPER DONUT	Sep 30, 1982	Substantially Equivalent	Alimed, Inc.
K821835	BARRIER BURN SHEET	Jul 02, 1982	Substantially Equivalent	Uhi Corp.
K820582	3M THINSULATE DISPOSABLE HOSPITAL BED	Mar 18, 1982	Substantially Equivalent	3M Company
K813519	NON-ABSORBENT TOWELS	Jan 05, 1982	Substantially Equivalent	Cunningham Woodland, Inc.
K813263	PATIENT UNDERPAD	Nov 27, 1981	Substantially Equivalent	The Buckeye Cellulose Corp.
K812079	DISPOSABLE PILLOW	Aug 04, 1981	Substantially Equivalent	Carpenter Co.
K811232	DISPOSABLE UNDERPADS	May 21, 1981	Substantially Equivalent	Burina
K810264	DISPOSABLE PILLOW	Feb 09, 1981	Substantially Equivalent	Anago, Inc.
K802998	PATIENT CARE DISPOSABLE INFANT SHIRTS	Dec 22, 1980	Substantially Equivalent	American Convertors Div., American Pharmaseal
K802740	FLUFF UNDERPAD TYPE UP1001	Dec 10, 1980	Substantially Equivalent	Bio D Corp.
K802730	FLUFF UNDERPAD TYPE UP1002	Dec 10, 1980	Substantially Equivalent	Bio D Corp.
K792626	STERILIZATION PROCESS/BABY BLANKET	Jan 16, 1980	Substantially Equivalent	Procter & Gamble Mfg. Co.
K790411	AUTO TRAUMA KIT	Jun 01, 1979	Substantially Equivalent	Marshall Electronics, Inc.
K790659	INFANT SCALE DISPOSABLE LINER	Apr 30, 1979	Substantially Equivalent	Hydro-Med Products, Inc.
K790283	PILLOW, CARTER ARM ELEVATION	Apr 06, 1979	Substantially Equivalent	Depuy, Inc.
K782001	ROSEALAE	Dec 07, 1978	Substantially Equivalent	Asmb
K781796	BEDDING, DISPOSABLE HOSPITAL	Dec 07, 1978	Substantially Equivalent	Kimberly-Clark Corp.
K781354	PILLOWS- SINGLE PATIENT USE	Oct 17, 1978	Substantially Equivalent	Abco Dealers, Inc.
K781227	TOWELS, SHEETS, PILLOWCASES	Oct 17, 1978	Substantially Equivalent	Abco Dealers, Inc.
K770486	SHEET KIT, STRETCHER, DISPOSABLE	Apr 29, 1977	Substantially Equivalent	American Hospital Supply Corp.
K761109	TERRYCLOTH BIBS	Dec 02, 1976	Substantially Equivalent	Fred Sammons, Inc.
K761108	PLASTIC DISPOSABLE BIB	Dec 02, 1976	Substantially Equivalent	Fred Sammons, Inc.