Product code EYQ
- Device name
- Garment, Protective, For Incontinence
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.5920
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950784 | DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM | Advanced Bioresearch Assoc. | 1995-05-03 |
| K932310 | KIT PAK INCONTINENT SKIN CARE KIT | Kit Pak, Inc. | 1994-06-01 |
| K903342 | DEODORIZING AND SOUND MUFFLING ANAL PAD | Biological Resistance, Inc. | 1990-10-23 |
| K891686 | LIB SYSTEM, BABY/ADULT DIAPER | Intera Corp. | 1989-05-31 |
| K885185 | INTERA SHIELD AND INTERA UNDERGARMENT | Intera Corp. | 1989-02-08 |
| K883895 | DRIPRIDE ULTRA INCONTINENT PAD | Weyerhaeuser Co. | 1989-01-30 |
| K883894 | DRIPRIDE PROVIDE SLIM | Weyerhaeuser Co. | 1989-01-30 |
| K883787 | REUSABLE ADULT INCONTINENT DIAPER | Intera Corp. | 1988-11-07 |
| K882418 | DRY COMFORT UNDERGARMENT | Health Tec, Inc. | 1988-09-29 |
| K880454 | AT EASE STRESS PAD | Hospital Specialty Co. | 1988-06-16 |
| K880455 | AT EASE ADULT DIAPER | Hospital Specialty Co. | 1988-04-14 |
| K880338 | CHICOPEE ADULT INCONTINENCE SHIELDS | Chicopee, Inc. | 1988-03-31 |
| K872059 | DRIPRIDE PROVIDE ULTRA | Weyerhaeuser Co. | 1988-03-16 |
| K873036 | ATTENDS INCONTINENT BRIEF | Procter & Gamble Mfg. Co. | 1988-01-19 |
| K862878 | FREE & ACTIVE(TM) ABSORBENT PADS | Convatec, A Division of E.R. Squibb & Sons | 1986-11-19 |
| K862877 | MALE URINARY STRESS PAD* | Convatec, A Division of E.R. Squibb & Sons | 1986-11-19 |
| K861863 | MODIFIED PROTECTIVE GARMENT | Procter & Gamble Mfg. Co. | 1986-08-11 |
| K862380 | MATTRESS COVER | Intera Corp. | 1986-07-28 |
| K860598 | MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS | Procter & Gamble Mfg. Co. | 1986-03-05 |
| K860459 | UNITY DISPOSABLE INCONTINENT BRIEF | Bevan Medical, Inc. | 1986-02-26 |
| K854730 | DAISY (ABSORBENT INCONTINENCE SHIELD) | Lic-Orthion | 1986-02-06 |
| K854729 | ADAM (ABSORBENT INCONTINENCE SHIELD) | Lic-Orthion | 1986-02-06 |
| K854378 | DEPEND FITTED BRIEF | Kimberly-Clark Corp. | 1985-12-02 |
| K854408 | ADULT ABSORBENT INCONTINENT BRIEF | Weyerhaeuser Co. | 1985-11-19 |
| K853740 | KAY PLUS ADULT DIAPER | Beghin_Say Intl., Inc. | 1985-10-17 |
| K853079 | PROTECTIVE PAD FOR INCONTINENCE | I.C.D. Industries, Inc. | 1985-08-09 |
| K852276 | ESTEEM INCONTINENT SYSTEM | Bevan Medical, Inc. | 1985-08-07 |
| K851876 | PREFER INCONTINENCE AID | Rocky Mountain Medical Corp. | 1985-06-12 |
| K850611 | ATTENDS INCONTINENT UNDERGARMENT | Procter & Gamble Mfg. Co. | 1985-02-26 |
| K850154 | DIGNITY PANT & ABSORBENT PADS | Convatec, A Division of E.R. Squibb & Sons | 1985-02-14 |
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|---|---|---|---|
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| 10840330704820 | ProCure | Twin Med, LLC | 2026-04-28 |
| 10840330704813 | ProCure | Twin Med, LLC | 2026-04-28 |
| M20890029852 | CUSTOMED | CUSTOMED INC | 2023-08-10 |
| M20890029842 | CUSTOMED | CUSTOMED INC | 2023-08-10 |
| M20890029882 | CUSTOMED | CUSTOMED INC | 2023-08-10 |
| M20890029872 | CUSTOMED | CUSTOMED INC | 2023-08-10 |
| M20890029862 | CUSTOMED | CUSTOMED INC | 2023-08-10 |
| 10694393126101 | Wings | Cardinal Health, Inc. | 2018-06-30 |
| 10694393126118 | Wings | Cardinal Health, Inc. | 2018-06-30 |
| 10884521194588 | Wings | Cardinal Health, Inc. | 2018-06-30 |
| 10694393126095 | Wings | Cardinal Health, Inc. | 2018-06-30 |
| 10884521081970 | Simplicity | Cardinal Health, Inc. | 2018-06-27 |
| 10884521194595 | Wings | Cardinal Health, Inc. | 2018-06-27 |
| 10884521081949 | Simplicity | Cardinal Health, Inc. | 2018-06-27 |
| 10694393126125 | Wings | Cardinal Health, Inc. | 2018-06-27 |
| 10884521527508 | Sure Care | Cardinal Health, Inc. | 2018-06-22 |
| 10884521194670 | Sure Care | Cardinal Health, Inc. | 2018-06-22 |
| 10884521194618 | Sure Care | Cardinal Health, Inc. | 2018-06-22 |
| 10884521158672 | Simplicity | Cardinal Health, Inc. | 2018-06-22 |
| 10884521158665 | Simplicity | Cardinal Health, Inc. | 2018-06-22 |
| 10884521158658 | Simplicity | Cardinal Health, Inc. | 2018-06-22 |
| 10884521158641 | Sure Care | Cardinal Health, Inc. | 2018-06-22 |
| 10884521158627 | Sure Care | Cardinal Health, Inc. | 2018-06-22 |
| 10884521158610 | Simplicity | Cardinal Health, Inc. | 2018-06-22 |
| 10884521158603 | Simplicity | Cardinal Health, Inc. | 2018-06-22 |
| 10884521158597 | Simplicity | Cardinal Health, Inc. | 2018-06-22 |
| 10884521158580 | Sure Care | Cardinal Health, Inc. | 2018-06-22 |
| 10884521158573 | Sure Care | Cardinal Health, Inc. | 2018-06-22 |
| 10884521104341 | Sure Care | Cardinal Health, Inc. | 2018-06-22 |