Bedding, Disposable, Medical

FDA product code KME · 65 cleared devices

Class 1 General Hospital

Regulation: 21 CFR 880.6060
Review panel: HO
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: Yes
Clearance span: 1976-12-02 – 2004-09-17

KME 2004-09-17

READY-HEAT BLANKET

Applicant Techtrade, LLC

K number K042145

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KME 1994-12-02

OREX MEDICAL BEDDING

Applicant Thantex Specialties, Inc.

K number K944953

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KME 1994-01-26

DISPOSE-A-SHEET

Applicant Belmac Healthcare Corp.

K number K933636

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KME 1993-11-02

DOCTOR DOWN --RESCUE WRAP

Applicant Three Dog Down

K number K932539

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KME 1992-08-10

AMERICAN BURN SHEET

Applicant American Silk Sutures, Inc.

K number K922143

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KME 1992-02-20

FOIL BABY BUNTING

Applicant Gam Industries, Inc.

K number K915303

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KME 1991-12-31

CHEM-SLEEVE B

Applicant Haz-Med, Inc.

K number K912257

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KME 1991-05-28

MEDI GUARD SHEETS/UNDERLAYS

Applicant Sancella, Inc.

K number K911953

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KME 1991-05-28

MEDI GUARD UNDERPAD

Applicant Sancella, Inc.

K number K911952

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KME 1991-05-28

MEDI GUARD PILLOWCASE

Applicant Sancella, Inc.

K number K911948

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KME 1991-05-21

MEDI GUARD DRAPES

Applicant Sancella, Inc.

K number K911950

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KME 1990-12-28

BIO-GUARD SHAVE PREP TRAY

Applicant Network Medical Systems, Inc.

K number K905003

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KME 1990-10-26

RECEIVING BLANKET

Applicant Anago, Inc.

K number K904274

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KME 1990-09-12

TRAUMA SLEEVE

Applicant Haz-Med, Inc.

K number K901509

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KME 1990-04-27

CHEM-SLEEVE

Applicant Haz-Med, Inc.

K number K901629

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KME 1990-04-25

FLUID SOAKERSHIELD

Applicant Infection Control Products, Inc.

K number K900643

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KME 1990-01-10

MATTRESS COVER FOR MEDICAL PURPOSES

Applicant Keystone Veterinary Supplies, Inc.

K number K896043

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KME 1989-12-29

MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE

Applicant Mark One Healthcare Products

K number K891986

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KME 1989-09-07

DEVON DISPOSABLE HEAD POSITIONER COVER

Applicant Devon Industries, Inc.

K number K894170

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KME 1988-11-08

BED SHEET, PILLOW CASE

Applicant Saybrex Intl., Inc.

K number K884380

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KME 1988-07-19

HEADREST, PATIENT COMFORT

Applicant Surgic Aid, Inc.

K number K882332

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KME 1988-06-07

DRY COMFORT DISPOSABLE UNDERPAD

Applicant Health Tec, Inc.

K number K881969

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KME 1988-06-03

DRIPRIDE DISPOSABLE UNDERPAD

Applicant Weyerhaeuser Co.

K number K881859

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KME 1987-05-15

DRIPRIDE DISPOSABLE UNDERPADS

Applicant Weyerhaeuser Co.

K number K871725

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KME 1987-03-17

PAD, BED LINEN PROTECTIVE

Applicant Quality Disposables, Inc.

K number K870925

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KME 1987-03-13

DEPEND UNDERPAD

Applicant Kimberly-Clark Corp.

K number K870522

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KME 1987-03-02

THERMAPAD

Applicant Avail-Southwest Division

K number K864158

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KME 1986-08-27

KIMLON DISPOSABLE BLANKET

Applicant Kimberly-Clark Corp.

K number K863179

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KME 1986-07-02

SINGLE-USE PATIENT UNDERPAD

Applicant Procter & Gamble Mfg. Co.

K number K862348

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KME 1986-02-19

REFLECTIVE BLANKET

Applicant O.R. Concepts, Inc.

K number K860066

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KME 1985-11-08

ALPHA CHUCK

Applicant Rocky Mountain Medical Corp.

K number K853970

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KME 1985-10-16

ATTENDS DISPOS. UNDERPAD

Applicant Procter & Gamble Mfg. Co.

K number K853880

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KME 1985-04-19

MEDICAL, DISPOSABLE BEDDING

Applicant East Texas Lighthouse For the Blind

K number K850067

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KME 1985-03-21

PAD, PRE-OPERATIVE PREPARATION

Applicant East Texas Lighthouse For the Blind

K number K850811

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KME 1985-03-12

SHAVE PREP TRAY

Applicant Packaging Technologies, Inc.

K number K850544

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KME 1984-12-04

WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT

Applicant Biological & Environmental Control Laboratories

K number K844196

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KME 1984-12-04

SHAVE PREP KITS

Applicant Biological & Environmental Control Laboratories

K number K842989

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KME 1984-10-24

DISPOSABLE PATIENT BLANKET

Applicant Anago, Inc.

K number K843038

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KME 1984-09-07

MOLINEA UNDERPADS

Applicant Paul Hartmann Corp.

K number K843402

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KME 1984-08-01

PILLOW W/STAPHCHEK TICKING

Applicant Monterey Mills, Inc.

K number K842335

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KME 1984-07-13

DISPOSABLE PILLOW

Applicant Monterey Mills, Inc.

K number K842336

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KME 1984-02-13

DRAW SHEET, ANTI-MICROBIAL

Applicant American Threshold Industries, Inc.

K number K832487

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KME 1984-02-13

PILLOW COVER, ANTI-MICROBIAL

Applicant American Threshold Industries, Inc.

K number K832486

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KME 1982-09-30

SUPER DONUT

Applicant Alimed, Inc.

K number K822650

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KME 1982-07-02

BARRIER BURN SHEET

Applicant Uhi Corp.

K number K821835

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KME 1982-03-18

3M THINSULATE DISPOSABLE HOSPITAL BED

Applicant 3M Company

K number K820582

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KME 1982-01-05

NON-ABSORBENT TOWELS

Applicant Cunningham Woodland, Inc.

K number K813519

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KME 1981-11-27

PATIENT UNDERPAD

Applicant The Buckeye Cellulose Corp.

K number K813263

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KME 1981-08-04

DISPOSABLE PILLOW

Applicant Carpenter Co.

K number K812079

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KME 1981-05-21

DISPOSABLE UNDERPADS

Applicant Burina

K number K811232

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KME 1981-02-09

DISPOSABLE PILLOW

Applicant Anago, Inc.

K number K810264

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KME 1980-12-22

PATIENT CARE DISPOSABLE INFANT SHIRTS

Applicant American Convertors Div., American Pharmaseal

K number K802998

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KME 1980-12-10

FLUFF UNDERPAD TYPE UP1001

Applicant Bio D Corp.

K number K802740

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KME 1980-12-10

FLUFF UNDERPAD TYPE UP1002

Applicant Bio D Corp.

K number K802730

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KME 1980-01-16

STERILIZATION PROCESS/BABY BLANKET

Applicant Procter & Gamble Mfg. Co.

K number K792626

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KME 1979-06-01

AUTO TRAUMA KIT

Applicant Marshall Electronics, Inc.

K number K790411

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KME 1979-04-30

INFANT SCALE DISPOSABLE LINER

Applicant Hydro-Med Products, Inc.

K number K790659

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KME 1979-04-06

PILLOW, CARTER ARM ELEVATION

Applicant Depuy, Inc.

K number K790283

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KME 1978-12-07

ROSEALAE

Applicant Asmb

K number K782001

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KME 1978-12-07

BEDDING, DISPOSABLE HOSPITAL

Applicant Kimberly-Clark Corp.

K number K781796

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KME 1978-10-17

PILLOWS- SINGLE PATIENT USE

Applicant Abco Dealers, Inc.

K number K781354

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KME 1978-10-17

TOWELS, SHEETS, PILLOWCASES

Applicant Abco Dealers, Inc.

K number K781227

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KME 1977-04-29

SHEET KIT, STRETCHER, DISPOSABLE

Applicant American Hospital Supply Corp.

K number K770486

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KME 1976-12-02

TERRYCLOTH BIBS

Applicant Fred Sammons, Inc.

K number K761109

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KME 1976-12-02

PLASTIC DISPOSABLE BIB

Applicant Fred Sammons, Inc.

K number K761108

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