Product code LKB
- Device name
- Pad, Alcohol, Device Disinfectant
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132380 | PREVANTICS DEVICE SWAB | Professional Disposables International, Inc. | 2014-08-27 |
| K121655 | BD ALCOHOL SWAB | Becton, Dickinson & CO | 2013-03-20 |
| K112791 | SITESCRUB IPA DEVICE | C. R. Bard | 2012-02-24 |
| K912161 | I.V. STARR KIT | Medical Device Inspection Co., Inc. | 1991-10-08 |
| K912731 | STERI-SWAB | Westlock Investments (Usa), Inc. | 1991-10-02 |
| K910735 | HEXIDIS ALCOHOL SWAB | Specialites Septodont | 1991-04-02 |
| K896898 | BOWEN ELECTRODE SKIN PREPATORY CLEANSER | Bowen & Company, Inc. | 1990-04-04 |
| K896835 | ALCOHOL PREP AND POVIDONE-IODINE PREP | Norpak Mfg., Inc. | 1990-01-11 |
| K894791 | BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE | Span-America Medical Systems, Inc. | 1989-10-03 |
| K893958 | BAXTER ACETONE-ALCOHOL PREP PADS, STERILE | Span-America Medical Systems, Inc. | 1989-10-03 |
| K892193 | QUICKPAD (ALCOHOL SWABS) | Holtsch Co., Inc. | 1989-08-04 |
| K883840 | DRI-VENT ARTERIAL BLOOD SAMPLING KIT | Concord Laboratories, Inc. | 1989-05-16 |
| K890514 | PRE-MOISTENED CLEANSING PAD | Bausch & Lomb, Inc. | 1989-04-10 |
| K870718 | AMERICAN ALCOHOL PREP PAD STERILE MEDIUM | Span-America Medical Systems, Inc. | 1987-05-07 |
| K860961 | GAMMA RADIATION STERILIZED ALCOHOL PREP PADS | H & P Industries, Inc. | 1986-04-09 |
| K852235 | STERETS INJECTION SWAB | Ellis Pharmaceutical Consulting, Inc. | 1985-06-07 |
| K833993 | ALCOHOL SWABS | Concord Laboratories, Inc. | 1984-01-30 |
| K833936 | ACETONE ALCOHOL SWABS | Concord Laboratories, Inc. | 1984-01-30 |
| K833185 | ACETONE ALCOHOL PREP PAD | Aplicare, Inc. | 1983-10-31 |
| K833183 | APLICARE ONE ACETONE ALCOHOL SWABSTICK | Aplicare, Inc. | 1983-10-31 |
| K833141 | ONE TIME ACETONE/ALCOHOL;SWAB STICKS | Acme United Corp. | 1983-10-31 |
| K833182 | APLICARE ALCOHOL PREP PAD | Aplicare, Inc. | 1983-10-27 |
| K833184 | APLICARE THREE ALCOHOL SWABSTICKS | Aplicare, Inc. | 1983-10-27 |
| K830330 | SAVETT ALCOHOL PREP | Cederroth, Inc. USA | 1983-03-17 |
| K813391 | TOBRAMYCIN REAGENT TEST KIT | Beckman Instruments, Inc. | 1981-12-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10192253045741 | Webcol | Cardinal Health 200, LLC | 2025-09-29 |
| 10192253047073 | Webcol | Cardinal Health 200, LLC | 2025-07-28 |
| 10192253047066 | Webcol | Cardinal Health 200, LLC | 2025-06-10 |
| 10192253046205 | Webcol | Cardinal Health 200, LLC | 2024-09-05 |
| 10653160373858 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-04-25 |
| 10850049784532 | SURGYCO | Surgyco LLC | 2023-12-15 |
| 10850049784556 | SURGYCO | Surgyco LLC | 2023-12-15 |
| 10801741086936 | SITE-SCRUB | Bard Access Systems, Inc. | 2023-12-13 |
| 10801741086943 | SITE-SCRUB | Bard Access Systems, Inc. | 2023-12-13 |
| 10193489190847 | MEDLINE | CENTURION MEDICAL PRODUCTS CORPORATION | 2020-04-24 |
| 30704411011877 | AMShield® Disinfecting Cap | AMSINO INTERNATIONAL, INC. | 2020-03-20 |
| 30704411011860 | AMShield® Disinfecting Cap | AMSINO INTERNATIONAL, INC. | 2020-03-20 |
| 10884450390730 | DualCap® | Merit Medical Systems, Inc. | 2018-09-24 |
| 10884527020607 | Webcol | Cardinal Health, Inc. | 2018-06-30 |
| 10884527020676 | Webcol | Cardinal Health, Inc. | 2018-06-30 |
| 10884527020591 | Webcol | Cardinal Health, Inc. | 2018-06-30 |
| 10884521183650 | Kendall | Cardinal Health, Inc. | 2018-06-30 |
| 10884521183667 | Kendall | Cardinal Health, Inc. | 2018-06-29 |
| 10884527020737 | Webcol | Cardinal Health, Inc. | 2018-06-27 |
| 20884527020642 | Webcol | Cardinal Health, Inc. | 2018-06-27 |
| 10884527020690 | Webcol | Cardinal Health, Inc. | 2018-06-22 |
| 10704411008422 | AMSure® Protective Cap | AMSINO INTERNATIONAL, INC. | 2018-06-05 |
| 10887488641805 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2017-05-03 |
| 30707387773756 | Curos™ | 3M COMPANY | 2016-10-13 |
| 30707387773770 | Curos™ | 3M COMPANY | 2016-10-13 |
| 30707387773794 | Curos™ | 3M COMPANY | 2016-10-13 |
| 30707387773817 | Curos™ Tego® | 3M COMPANY | 2016-10-13 |
| 30382903065579 | BD PosiFlush SureScrub | BECTON, DICKINSON AND COMPANY | 2016-09-19 |
| 30382903065586 | BD PosiFlush SureScrub | BECTON, DICKINSON AND COMPANY | 2016-09-19 |
| 10885425997381 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-07-05 |