FDA 510(k) Applications for Medical Device Product Code "KKX"
(Drape, Surgical)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K043015 | 3L MEDICAL PRODUCTS CO., LTD. | 3L SURGICAL DRAPES | 08/15/2005 |
| K222578 | 3M Company | 3MÖ IobanÖ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | 05/18/2023 |
| K031287 | 3M COMPANY | STERI-DRAPE SURGICAL DRAPES | 09/10/2003 |
| K140250 | 3M HEALTH CARE | 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE | 07/25/2014 |
| K140330 | 3M HEALTH CARE | 3M STERI-DRAPE FABRIC SURGICAL DRAPES | 08/18/2014 |
| K102861 | A PLUS INTERNATIONAL, INC. | SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE) | 01/13/2011 |
| K012168 | ADVANCE MEDICAL DESIGNS, INC. | ADVANCE MEDICAL DESIGNS FLUID POUCH | 09/18/2001 |
| K053495 | ADVANCE MEDICAL DESIGNS, INC. | EQUIPMENT SLUSH DRAPE | 03/16/2006 |
| K003670 | ADVANCE MEDICAL DESIGNS, INC. | PATIENT DRAPE, SURGICAL | 01/26/2001 |
| K011422 | ADVANCE MEDICAL DESIGNS, INC. | SURGICAL DRAPES | 07/10/2001 |
| K010711 | ADVANCED SURGICAL CONCEPTS (ASC) | ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR | 05/22/2001 |
| K131571 | ADVANCED VASCULAR DYNAMICS | AVD RIGHT RADIAL DRAPE | 01/31/2014 |
| K002419 | ALLEGIANCE HEALTHCARE COPORATION | SURGICAL DRAPES | 08/15/2000 |
| K964125 | ALLEGIANCE HEALTHCARE CORP. | CONVERTORS DRAPE MATERIAL | 12/23/1996 |
| K000417 | ALLEGIANCE HEALTHCARE CORP. | CONVERTORS EQUIPMENT DRAPES | 03/17/2000 |
| K970554 | ALLEGIANCE HEALTHCARE CORP. | CONVERTORS SMS DRAPES | 05/27/1997 |
| K993795 | ALLEGIANCE HEALTHCARE CORP. | CONVERTORS SURGICAL DRAPES | 01/12/2000 |
| K981818 | ALLEGIANCE HEALTHCARE CORP. | CONVERTORS TRILAMINATE DRAPES | 07/10/1998 |
| K023425 | ALLEGIANCE HEALTHCARE CORP. | DRAPES WITH ABSORBENT REINFORCEMENT | 11/06/2002 |
| K002508 | ALLEGIANCE HEALTHCARE CORP. | EQUIPMENT DRAPES | 09/01/2000 |
| K001667 | ALLEGIANCE HEALTHCARE CORP. | RESOLVE SURGICAL O.R. TOWELS | 06/23/2000 |
| K023419 | ALLEGIANCE HEALTHCARE CORP. | TRILAMINATE DRAPES/TIBURON | 02/11/2003 |
| K990253 | AMBA MEDICAL LTD. | SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600 | 09/24/1999 |
| K972187 | AMERICAN SEAL CO. | BOUFFANT CAP | 09/09/1997 |
| K031889 | APPLIED MEDICAL RESOURCES CORP. | ALEXIS WOUND RETRACTOR | 09/22/2003 |
| K020435 | APPLIED MEDICAL RESOURCES CORP. | WOUND PROTECTOR/RETRACTOR | 04/15/2002 |
| K071491 | ARROW INTL., INC. | ARROW INTERNATIONAL, INC., SURGICAL DRAPES | 10/10/2007 |
| K061422 | AUSTIN MEDICAL, INC. | SURGICAL DRAPES | 09/25/2006 |
| K202208 | Avery Dennison Belgie BVBA | BeneHold Surgical Incise Drape with CHG antimicrobial | 07/30/2021 |
| K981823 | BALDUR SYSTEMS CORP. | OPERATING ROOM TOWELS | 08/11/1998 |
| K010572 | BECTON DICKINSON AND CO. | BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE | 03/12/2001 |
| K991667 | BROADLINE MEDICAL INDUSTRIES | BROADLINE OR TOWELS | 09/27/1999 |
| K083424 | BUSSE HOSIPITAL DISPOSABLES | BUSSE SURGICAL DRAPE | 02/26/2009 |
| K082297 | BUSSE HOSPITAL DISPOSABLES, INC. | BUSSE SURGICAL DRAPE | 12/09/2008 |
| K092212 | BUSSE HOSPITAL DISPOSABLES, INC. | BUSSE SURGICAL DRAPES III | 10/09/2009 |
| K093909 | BUSSE HOSPITAL DISPOSABLES, INC. | BUSSE SURGICAL DRAPES IV | 05/06/2010 |
| K130404 | CARDINAL HEALTH 200, LLC | TIBURON SURGICAL DRAPE | 07/05/2013 |
| K061762 | CARDINAL HEALTH, INC. | TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N | 08/01/2006 |
| K122000 | CHANGZHOU HOLYMED PRODUCTS CO LTD | HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER | 12/12/2012 |
| K001858 | CHINA NANTONG GUANGDA TEXTILE CO., LTD. | OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE | 08/17/2000 |
| K112378 | COBES INDUSTRIES CO., LTD. | COBES SURGICAL DRAPE | 05/08/2012 |
| K002691 | COM-MED INTERNATIONAL, INC. | COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE | 12/08/2000 |
| K970185 | CONTOUR FABRICATORS, INC. | STERILE DISPOSABLE EQUIPMENT MAGNET COVER | 04/10/1997 |
| K200238 | ControlRad, Inc | ControlRad Sterile Cover | 04/26/2020 |
| K163556 | COVALON TECHNOLOGIES, INC. | MediClear PreOp | 09/14/2017 |
| K140064 | COVIDIEN | SURGISLEEVE WOUND PROTECTOR | 03/12/2014 |
| K994199 | CUSTOM MEDICAL PRODUCTS, INC. | VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR | 06/09/2000 |
| K960242 | CUSTOM PACK RELIABILITY | CPR EYE TRAY | 03/12/1996 |
| K974647 | CUSTOMED, INC. | FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 | 01/05/1998 |
| K121436 | DAS MEDICAL, LLC | DAS MEDICAL EQUIPMENT DRAPES | 06/06/2013 |
| K994211 | DENTSPLY INTL. | ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285 | 02/04/2000 |
| K030908 | DEROYAL | DEROYAL SURGICAL DRAPES BACKTABLE COVER | 08/11/2003 |
| K030365 | DEROYAL INDUSTRIES, INC. | DEROYAL DRAPES, STERILE, NON-STERILE | 04/29/2003 |
| K083320 | DUKAL CORP. | DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE | 03/06/2009 |
| K012957 | DYNAREX CORP. | TOWEL DRAPE, MODELS 4409, 4410 | 03/06/2002 |
| K001994 | EAGLE ENDOSCOPIC, INC. | EEI SLUSH PAN DRAPE | 08/04/2000 |
| K101689 | EXACT MEDICAL MANUFACTURING, INC | EMM EQUIPMENT COVER-POLYTHYLENE | 09/20/2010 |
| K101598 | EXACT MEDICAL MANUFACTURING, INC | EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) | 10/04/2010 |
| K101688 | EXACT MEDICAL MANUFACTURING, INC | EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 | 09/20/2010 |
| K121919 | EXACT MEDICAL MANUFACTURING, INC | SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV | 02/14/2013 |
| K955749 | FLYNT AMTEX, INC. | TEX-CARE STERILE STOCKINETTE | 11/22/1996 |
| K041224 | FOOTHILLS INDUSTRIES, INC. | FOOTHILLS SURGICAL DRAPES | 02/03/2005 |
| K133080 | FOSHAN NANHAI PLUS MEDICAL CO., LTD. | Plus Surgical Drapes (EO Sterilized), PMDB-XXX | 06/24/2015 |
| K980210 | GEL-LITE, L.L.C. | VARIOUS SURGICAL OR PATIENT DRAPES | 05/15/1998 |
| K111458 | GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. | GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS | 12/01/2011 |
| K140195 | GRIFFITH-LUCAS LLC | SURGICAL DRAPE | 09/10/2014 |
| K002702 | GYRUS ENT L.L.C. | NEUROTOLOGY DRAPE, MODEL TBD | 10/26/2000 |
| K050508 | HAYWOOD VOCATIONAL OPPORTUNITIES | HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES | 04/27/2005 |
| K094016 | HINSON AND HALE MEDICAL TECHNOLOGIES, INC | NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, H | 11/19/2010 |
| K041077 | IMALUX CORPORATION | IMALUX OCT PROBE GUIDE | 06/25/2004 |
| K013958 | INDUS TEXTILES, INC. | INDUS TEXTILES TOWEL-STERILE AND NON-STERILE | 08/19/2002 |
| K100208 | INTERNATIONAL MEDSURG CONNECTION | IMC SURGICAL DRAPE | 04/20/2010 |
| K100991 | INTERNATIONAL MEDSURG CONNECTION | IMC SURGICAL DRAPE | 10/05/2010 |
| K971159 | INTERNATIONAL MEDSURG CONNECTION | SURGICAL DRAPES | 06/24/1997 |
| K052169 | INTERNATIONAL MEDSURG CONNECTION, INC. | IMC SURGICAL DRAPES | 11/17/2005 |
| K042893 | INTERNATIONAL MEDSURG CONNECTION, INC. | UNDER BUTTOCKS DRAPE | 03/11/2005 |
| K050538 | INTL. MEDSURG CONNECTION, INC. | IMC DRAPES | 06/07/2005 |
| K062480 | JOYKEY INDUSTRYIAL LTD. | JOYKEY SURGICAL DRAPES (STERILE) | 03/05/2007 |
| K083234 | KIMBERLY-CLARK CORP. | KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 | 03/25/2009 |
| K102666 | KIMBERLY-CLARK CORP. | KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM | 11/09/2010 |
| K112136 | KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD. | TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE | 09/29/2011 |
| K031362 | LAC MAC, LTD. | LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS | 05/30/2003 |
| K020393 | MASTER & FRANK ENTERPRSES CO.LTD. | MASTER & FRANK SURGICAL DRAPES (STERILE) | 05/03/2002 |
| K955872 | MEDAL INTL. SALES CO., LLC. | VOLMED OPERATION DRAPE | 03/12/1996 |
| K042526 | MEDICAL ACTION INDUSTRIES, INC. | DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX | 04/25/2005 |
| K000442 | MEDICAL CONCEPTS DEVELOPMENT, INC. | ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX | 04/24/2001 |
| K020581 | MEDICAL CONCEPTS DEVELOPMENT, INC. | COLOSHIELD COLONOSCOPY DRAPE MODEL E2000 | 09/18/2002 |
| K954824 | MEDICAL CREATIVE TECHNOLOGIES, INC. | PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE | 04/23/1996 |
| K974672 | MEDICAL SPECIALTY INNOVATIONS, INC. (MSI) | MSI SURGICAL DRAPES | 03/13/1998 |
| K052833 | MEDLINE INDUSTRIES, INC. | GORE-TEX NON-STERILE SURGICAL GOWNS | 02/15/2006 |
| K023432 | MEDLINE INDUSTRIES, INC. | MEDLINE ASEP PLUS SURGICAL DRAPES | 11/04/2002 |
| K964142 | MEDLINE INDUSTRIES, INC. | MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS | 02/25/1997 |
| K032666 | MEDLINE INDUSTRIES, INC. | MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES | 03/16/2005 |
| K962205 | MEDLINE INDUSTRIES, INC. | STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE | 11/26/1996 |
| K973146 | MENTOR OPHTHALMICS, INC. | MENTOR SUPER ABSORBENT DRAPE | 12/04/1997 |
| K012237 | MERCAN AB | MERTEX-PLUS REUSABLE SURGICAL DRAPE | 10/15/2001 |
| K963675 | MICRO-MEDICAL DEVICES, INC. | THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE | 01/27/1997 |
| K050322 | MICROTEK MEDICAL, INC. | MICROTEK EQUIPMENT DRAPES | 05/17/2005 |
| K060200 | MICROTEK MEDICAL, INC. | MICROTEK MEDICAL WARMING DRAPE | 05/31/2006 |
| K041846 | MINRAD, INC. | SABRESOURCE DRAPE | 08/26/2004 |
| K031131 | MOLNLYCKE HEALTH CARE | KLINIDRAPE SURGICAL DRAPES | 06/10/2003 |
| K051625 | MOLNLYCKE HEALTH CARE, INC. | BARRIER SURGICAL DRAPES | 07/14/2005 |
| K000906 | MOLNLYCKE HEALTH CARE, INC. | KLINIDRAPE SURGICAL DRAPES | 06/23/2000 |
| K991548 | NOVED MEDICAL | HAL SCOPE HOLDER SYSTEM | 06/23/1999 |
| K042977 | ODYSSEY MEDICAL, INC. | LASIK EYE DRAPE | 05/10/2005 |
| K971089 | OPPORTUNITY, INC. | OPPORTUNITY, INC. LACERATION TRAY | 09/16/1997 |
| K052668 | OR SPECIFIC, INC. | OR SPECIFIC BIG CASE BACK TABLE COVER | 07/24/2006 |
| K021864 | PRIMELINE MEDICAL PRODUCTS, INC. | PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142) | 09/23/2002 |
| K022868 | PRIMELINE MEDICAL PRODUCTS, INC. | PRIMAGARD SURGICAL EQUIPMENT DRAPES | 11/08/2002 |
| K023117 | PRIMELINE MEDICAL PRODUCTS, INC. | PRIMAGARD SURGICAL GOWNS | 11/08/2002 |
| K042131 | PROMEDICAL PRODUCTS CO., LTD. | PROMEDICAL SURGICAL DRAPES | 12/10/2004 |
| K080629 | PROMEDICAL PRODUCTS CO., LTD. | PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS | 10/20/2008 |
| K042137 | PROMEDICAL PRODUCTS CO., LTD. | PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS | 10/05/2004 |
| K970891 | PROTEK MEDICAL PRODUCTS, INC. | DRAPE, SURGICAL-LATEX | 08/22/1997 |
| K970889 | PROTEK MEDICAL PRODUCTS, INC. | ULTRASOUND TRANSDUCER DRAPE | 10/20/1997 |
| K101350 | RADSCAN MEDICAL EQUIPMENT, INC. | RADSCAN EQUIPMENT SLICKER | 01/04/2011 |
| K960803 | RX TEXTILES, INC. | RX TEXTILES STERILE STOCKINETTE | 07/12/1996 |
| K080796 | SRI/SURGICAL EXPRESS | SRI LP DRAPE | 11/17/2008 |
| K012807 | STANDARD TEXTILE CO., INC. | MODIFICATION TO: COMPEL SURGICAL DRAPES | 10/11/2001 |
| K980183 | STANDARD TEXTILE CO., INC. | PROMAX SURGICAL DRAPES AND COVERS | 02/26/1998 |
| K081476 | SURGICAL CONCEPT DESIGNS | SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE | 08/08/2008 |
| K091343 | SURGIVISION, INC. | MRI NEURO DRAPE | 09/22/2009 |
| K962003 | TAUT, INC. | TUAT SPLATTER CONTROL SHIELD SCS-300 | 07/18/1996 |
| K960045 | THE SEWING SOURCE, INC. | ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE | 06/05/1996 |
| K970722 | TRINITY LABORATORIES, INC. | EYE TRAY | 03/31/1997 |
| K052395 | VOLCANO CORPORATION | STERILE EQUIPMENT COVERS | 12/01/2005 |
| K070406 | VORTEK SURGICAL, LLC | ENDODRAPE | 07/30/2007 |
| K080341 | VORTEK SURGICAL, LLC | ENDODRAPE(TM) | 07/21/2008 |
| K141324 | WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD | HONGYU DISPOSABLE SURGICAL DRAPES | 04/14/2015 |
| K070432 | WELMED INC. | GENERAL SURGERY DRAPES | 09/24/2007 |
| K141438 | WHITNEY MEDICAL SOLUTIONS | WHITNEY MEDICAL SOLUTIONS ESHIELD | 08/14/2014 |
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