Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Wrap, Sterilization

FDA product code FRG · 303 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.6850
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-12-02 – 2026-07-02

FRG 1994-02-07

CARAPACE DEBRIDEMENT KITS

Applicant Carapace, Inc.

K number K931669

View details →

FRG 1993-12-16

STERILIZATION WRAP-STERISHEET

Applicant Arjo Wiggins Medical, Inc.

K number K931202

View details →

FRG 1993-12-13

CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM

Applicant Contour Fabricators of Florida, Inc.

K number K933151

View details →

FRG 1993-12-13

LACERATION TRAY

Applicant Clinipad Corp.

K number K932036

View details →

FRG 1993-04-08

WRAPPEL T

Applicant Standard Textile Co., Inc.

K number K923408

View details →

FRG 1992-12-29

BASIC DRESSING CHANGE TRAY SMP 102A

Applicant Specialty Medical Products Co.

K number K922845

View details →

FRG 1992-10-28

CONVERTORS STERILIZATION WRAP

Applicant Baxter Healthcare Corp

K number K921243

View details →

FRG 1992-10-19

DRESSING CHANG & WOUND MANAGEMENT

Applicant Cypress Medical Products, Ltd.

K number K920480

View details →

FRG 1992-10-05

DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISP

Applicant Trinity Laboratories, Inc.

K number K921490

View details →

FRG 1992-04-23

DRESSING CHANGE TRAY

Applicant Medikmark, Inc.

K number K920339

View details →

FRG 1992-01-31

SUTURE REMOVAL KIT

Applicant Westmark Hospital Supplies

K number K914932

View details →

FRG 1991-06-24

MONARCH STERILIZATION CONTAINER SYST, MODIFICATION

Applicant Monarch Products, Inc.

K number K911760

View details →

FRG 1990-01-10

PEEL-VUE AUTOCLAVE/CHEMICALVE POUCH

Applicant Clive Craig Co.

K number K894437

View details →

FRG 1989-08-15

STERILIZATION TRAY LINER

Applicant Ahlstrom Dexter

K number K893764

View details →

FRG 1989-01-25

BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI.

Applicant Bemis Health Care

K number K885019

View details →

FRG 1988-10-21

CARETEX CENTRAL SUPPLY WRAP

Applicant James River Corp.

K number K883802

View details →

FRG 1988-09-28

STERILIZATION WRAP TYPE 22,44,77

Applicant East Texas Lighthouse For the Blind

K number K883376

View details →

FRG 1988-08-10

KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP

Applicant Kimberly-Clark Corp.

K number K881471

View details →

FRG 1987-09-09

CENTRAL SUPPLY ROOM WRAP

Applicant Ulti-Med Intl., Inc.

K number K873175

View details →

FRG 1987-08-06

HEALTH-PAK/WYCOMBE CSR WRAP

Applicant Health-Pak, Inc.

K number K872754

View details →

FRG 1987-07-21

FILM AND PAPER COMBINATION STERILIZING BAG

Applicant Cost Rite Health Products, Inc.

K number K871798

View details →

FRG 1987-05-29

FLASHPAK CONTAINER SYSTEM

Applicant Performance Instruments Corp.

K number K871202

View details →

FRG 1987-04-23

CARERITE & COST RITE NYLON STERILIZATION FILM

Applicant Cost Rite Health Products, Inc.

K number K870147

View details →

FRG 1986-11-25

STERILIZATION WRAPS #620,624,648,640,636,630,612

Applicant Graham Medical Products

K number K863981

View details →

FRG 1986-08-01

STANDARD BASIN KIT CUSTOM BASIN KIT

Applicant Quali-Med, Inc.

K number K862241

View details →

FRG 1985-09-16

STERILIZATION CONTAINER

Applicant Bemis Mfg. Co.

K number K852335

View details →

FRG 1985-08-15

MONARCH STERILIZATION CONTAINER SYSTEM

Applicant Monarch Products, Inc.

K number K850289

View details →

FRG 1985-06-07

KIMGUARD PROCEDURE TRAY

Applicant Kimberly-Clark Corp.

K number K852203

View details →

FRG 1985-05-01

ABCO INSTRUMENT PACKS & TRAYS

Applicant Abco Dealers, Inc.

K number K851315

View details →

FRG 1985-04-24

BLUE SEAL II STERILIZATION POUCH

Applicant American Sterilizer Co.

K number K851340

View details →

FRG 1985-04-01

CSR WRAP - CENTRAL SUPPLY ROOM WRAP FOR STERIL-

Applicant Papeteries Depont-Audemer

K number K844920

View details →

FRG 1985-02-22

INSTRUTAINER

Applicant Intrumed, Inc.

K number K844672

View details →

FRG 1984-12-19

SINGLE BASIN SET

Applicant Packaging Technologies, Inc.

K number K844611

View details →

FRG 1984-11-08

TPN/HYPERALIMENTATION TRAY

Applicant Deroyal Industries, Inc.

K number K842644

View details →

FRG 1984-10-31

O.B. BASIN SET

Applicant Pro-Lab, Inc.

K number K843982

View details →

FRG 1984-08-17

SKIN SCRUB TRAY STERILE SKIN SCRUB KIT

Applicant Biological & Environmental Control Laboratories

K number K842490

View details →

FRG 1984-08-15

DR. GOULD HAND PACK SUSTOM STERIL

Applicant Pro-Lab, Inc.

K number K842405

View details →

FRG 1984-07-06

STERILE PAN SET

Applicant Medi-Plast Intl., Inc.

K number K842136

View details →

FRG 1984-07-02

STERILE O.R. BASIN KIT PRODUCT LINE

Applicant Medline Industries, Inc.

K number K841484

View details →

FRG 1984-04-17

DRESSING CHANGE TRAY

Applicant Medcare Products

K number K841123

View details →

FRG 1984-04-13

VANTAGE E

Applicant American Sterilizer Co.

K number K841156

View details →

FRG 1984-03-27

PDI PREPMASTER WET PACK PATIENT PREP KIT

Applicant Nice-Pak Products, Inc.

K number K840342

View details →

FRG 1984-03-26

PDI PREPMASTER WET PACK MINOR PROCEDURE

Applicant Nice-Pak Products, Inc.

K number K840344

View details →

FRG 1984-03-19

E-Z OPEN DUST COVERS

Applicant Plasti-Products, Inc.

K number K840595

View details →

FRG 1984-02-10

JAKOBI SURG. INSTRUMENTS #2 70/71

Applicant Imm Enterprises , Ltd.

K number K834193

View details →

FRG 1983-11-03

STERILIZATION CONTAINER

Applicant Medin Corp.

K number K833343

View details →

FRG 1983-06-02

MDT CHEMITEST SEE-THRU BAG

Applicant Kenpak Converters, Inc.

K number K831425

View details →

FRG 1983-03-31

OR PREP KIT

Applicant Clinipad Corp.

K number K830476

View details →

FRG 1983-03-29

PRO-GUARD

Applicant Surgicot, Inc.

K number K830739

View details →

FRG 1983-03-17

RENNCO MODEL LS LIFT SEAL HEAT SEALER

Applicant Rennco, Inc.

K number K830540

View details →

FRG 1983-03-11

SKIN SCRUB PREP. TRAY

Applicant Zoa, Inc.

K number K830281

View details →

FRG 1983-01-09

EAGLE STERISET

Applicant American Sterilizer Co.

K number K823902

View details →

FRG 1983-01-07

CENTRAL SUPPLY ROOM WRAP

Applicant James River Corp.

K number K823513

View details →

FRG 1982-11-22

VIEW-PACK & MULTI POUCH

Applicant Sbw Medical Packaging, Inc.

K number K823223

View details →

FRG 1982-10-26

SCR WRAP

Applicant Fox Converting, Inc.

K number K822931

View details →

FRG 1982-09-21

SURGILITE NON-WOVEN WRAP

Applicant Surgilite Intl., Inc.

K number K822482

View details →

FRG 1982-08-16

STERILE HD PAN SET

Applicant Hospital Disposables, Inc.

K number K822211

View details →

FRG 1982-06-23

PATIENT PREP KITS/TRAYS-STERILE

Applicant Phoenix Glove Co.

K number K821044

View details →

FRG 1982-06-07

MEDI-SEAL STERILIZATION POUCHES & TUB

Applicant Medical Industries Packaging, Inc.

K number K821331

View details →

FRG 1982-06-07

GAS STERILIZATION POUCHES

Applicant Medical Industries Packaging, Inc.

K number K821330

View details →

FRG 1982-06-02

STERILE HD PAN SET

Applicant Hospital Disposables, Inc.

K number K821482

View details →

FRG 1982-04-09

C.S.R. WRAPPERS

Applicant General Medical Co.

K number K820689

View details →

FRG 1982-04-09

ECONOMY LINE OF TRAYS

Applicant Abco Dealers, Inc.

K number K820589

View details →

FRG 1982-03-18

STERILIZATION WRAP

Applicant General Medical Co.

K number K820521

View details →

FRG 1982-03-02

SUBCLAVIAN INSERTION KIT

Applicant Clinipad Corp.

K number K820171

View details →

FRG 1982-02-24

SURGIPEEL SELF-SEAL PACKAGING SYSTEM

Applicant Surgicot, Inc.

K number K820302

View details →

FRG 1981-12-31

PAN SET

Applicant Sterile Design, Inc.

K number K813437

View details →

FRG 1981-08-04

BOUNDARY STERILIZATION WRAP

Applicant The Buckeye Cellulose Corp.

K number K811819

View details →

FRG 1981-07-10

STERI-LOK DUAL PURPOSE PACKAGING/8400

Applicant 3M Company

K number K811670

View details →

FRG 1981-06-12

CATHETER MAINTENANCE KIT

Applicant Clinipad Corp.

K number K811247

View details →

FRG 1981-05-21

DISPOSABLE STERILIZATION WRAP

Applicant Amsco Co.

K number K811242

View details →

FRG 1981-05-21

ROLL-A-SET

Applicant Principle Business Ent.

K number K810918

View details →

FRG 1981-03-20

OR/CS WRAP

Applicant American Threshold Industries, Inc.

K number K810646

View details →

FRG 1981-02-05

ALOFT STERILIZATION WRAP

Applicant American Hospital Supply Corp.

K number K803306

View details →

FRG 1981-02-02

GUARDIAN STERILIZATION WRAP

Applicant Kimberly-Clark Corp.

K number K803294

View details →

FRG 1981-02-02

ISO-BAC INSTRUMENT WRAP

Applicant American Convertors Div., American Pharmaseal

K number K802919

View details →

FRG 1981-01-28

GUARDIAN PEEL POUCHES

Applicant Kimberly-Clark Corp.

K number K803293

View details →

FRG 1980-11-12

HYPERALIMENTATION SUBCLAVIIAN DRESS TRAY

Applicant Associated Medical Products Co.

K number K802577

View details →

FRG 1980-10-23

PROPPER SHARPGUARD & TRAYPAD STERIL. AID

Applicant Propper Mfg. Co., Inc.

K number K802428

View details →

FRG 1980-08-22

AMPCO DRESSING CHANGE TRAYS

Applicant Associated Medical Products Co.

K number K801333

View details →

FRG 1980-08-20

AMPCO HYPERALIMENTATION SUBCLAVIAN TRAYS

Applicant Associated Medical Products Co.

K number K801331

View details →

FRG 1980-07-28

VAL-U-WRAP CSR WRAP

Applicant American Convertors Div., American Pharmaseal

K number K801569

View details →

FRG 1980-06-20

AMPCO SKIN SCRUB TRAYS

Applicant Associated Medical Products Co.

K number K801332

View details →

FRG 1980-02-13

DEXTEX II STERILIZATION WRAP

Applicant Ahlstrom Dexter

K number K800123

View details →

FRG 1979-12-10

HYPERALIMENTATION DRESSING TRAY

Applicant Pharmaseal Div., Baxter Healthcare Corp.

K number K792369

View details →

FRG 1979-10-11

ADAMCO DUST COVER

Applicant Chase Mfg. Co.

K number K791513

View details →

FRG 1978-12-07

DECONTAMINATION ITEMS BAG

Applicant Medicare Industries, Inc.

K number K781981

View details →

FRG 1978-12-07

RESPIRATORY THERAPY GAS POUCH

Applicant Medicare Industries, Inc.

K number K781980

View details →

FRG 1978-11-22

POUCHES, GAS STERILIZATION

Applicant Medicare Industries, Inc.

K number K781925

View details →

FRG 1978-11-22

POUCHES AND TUBING, MEDI-SEAL

Applicant Medicare Industries, Inc.

K number K781924

View details →

FRG 1978-08-10

WRAP, STERILIZATION

Applicant Stanford Professional Products

K number K781301

View details →

FRG 1978-03-28

G WRAP

Applicant Cel-Fibe

K number K780294

View details →

FRG 1978-02-21

AUTOCLAVE POUCHES&ROLLS/STEAM&GAS

Applicant E.M. Adams

K number K780034

View details →

FRG 1977-10-13

SUOGIPEEL PACKAGING SYSTEM

Applicant Surgicot, Inc.

K number K771846

View details →

FRG 1977-09-02

BIO-SHIELD CSR WRAP

Applicant Convertors

K number K770933

View details →

FRG 1977-08-02

ECONOWRAP PAPER C.S.R. WRAP

Applicant Tower Products, Inc.

K number K771348

View details →

FRG 1977-07-14

POUCHES, PEEL OPEN, BREATHABLE

Applicant Surgicot, Inc.

K number K771032

View details →

FRG 1977-07-11

TRAY, CATHETERIZATION W/FOLEY, STERILE

Applicant Lukens Corp.

K number K770797

View details →

FRG 1977-04-15

STERI-STOR TM

Applicant Research Surgical Systems

K number K770409

View details →

FRG 1977-04-07

STERILIZER WRAP

Applicant C.R. Bard, Inc.

K number K770514

View details →

↑