Garment, Protective, For Incontinence
FDA product code EYQ · Class I (low risk) · 21 CFR 876.5920 · Gastroenterology, Urology
56510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
- Procter & Gamble Mfg. Co. 6
- Weyerhaeuser Co. 5
- Intera Corp. 4
- Convatec, A Division of E.R. Squibb & Sons 4
- Ipco Corp. 4
- Paul Hartmann Corp. 3
- Beghin_Say Intl., Inc. 2
- Lic-Orthion 2
- Bevan Medical, Inc. 2
- Hospital Specialty Co. 2
- Principle Business Ent. 2
- Fibre Formations, Inc. 2
- Kimberly-Clark Corp. 2
- Johnson & Johnson Professionals, Inc. 2
- Parke-Davis Co. 1
- Telcam Medical Devices, Inc. 1
- Advanced Bioresearch Assoc. 1
- Dafoe & Dafoe, Inc. 1
- Chesebrough-Pond'S U.S.A. Co. 1
- H.A. & J.E. Wood, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950784 | Dristar Urinary Incontinence Management SystemEYQ · Traditional | Advanced Bioresearch Assoc. | 05/03/1995SE |
| K932310 | Kit Pak Incontinent Skin Care KitEYQ · Traditional | Kit Pak, Inc. | 06/01/1994SEKD |
| K903342 | Deodorizing and Sound Muffling Anal PadEYQ · Traditional | Biological Resistance, Inc. | 10/23/1990SE |
| K891686 | Lib System, Baby/Adult DiaperEYQ · Traditional | Intera Corp. | 05/31/1989SE |
| K885185 | Intera Shield and Intera UndergarmentEYQ · Traditional | Intera Corp. | 02/08/1989SE |
| K883895 | Dripride Ultra Incontinent PadEYQ · Traditional | Weyerhaeuser Co. | 01/30/1989SE |
| K883894 | Dripride Provide SlimEYQ · Traditional | Weyerhaeuser Co. | 01/30/1989SE |
| K883787 | Reusable Adult Incontinent DiaperEYQ · Traditional | Intera Corp. | 11/07/1988SE |
| K882418 | Dry Comfort UndergarmentEYQ · Traditional | Health Tec, Inc. | 09/29/1988SE |
| K880454 | At Ease Stress PadEYQ · Traditional | Hospital Specialty Co. | 06/16/1988SE |
| K880455 | At Ease Adult DiaperEYQ · Traditional | Hospital Specialty Co. | 04/14/1988SE |
| K880338 | Chicopee Adult Incontinence ShieldsEYQ · Traditional | Chicopee, Inc. | 03/31/1988SE |
| K872059 | Dripride Provide UltraEYQ · Traditional | Weyerhaeuser Co. | 03/16/1988SE |
| K873036 | Attends Incontinent BriefEYQ · Traditional | Procter & Gamble Mfg. Co. | 01/19/1988SE |
| K862878 | Free & Active(Tm) Absorbent PadsEYQ · Traditional | Convatec, A Division of E.R. Squibb & Sons | 11/19/1986SE |
| K862877 | Male Urinary Stress Pad*EYQ · Traditional | Convatec, A Division of E.R. Squibb & Sons | 11/19/1986SE |
| K861863 | Modified Protective GarmentEYQ · Traditional | Procter & Gamble Mfg. Co. | 08/11/1986SE |
| K862380 | Mattress CoverEYQ · Traditional | Intera Corp. | 07/28/1986SE |
| K860598 | Modified Protective Garment for IncontinentsEYQ · Traditional | Procter & Gamble Mfg. Co. | 03/05/1986SE |
| K860459 | Unity Disposable Incontinent BriefEYQ · Traditional | Bevan Medical, Inc. | 02/26/1986SE |
| K854730 | Daisy (Absorbent Incontinence Shield)EYQ · Traditional | Lic-Orthion | 02/06/1986SE |
| K854729 | Adam (Absorbent Incontinence Shield)EYQ · Traditional | Lic-Orthion | 02/06/1986SE |
| K854378 | Depend Fitted BriefEYQ · Traditional | Kimberly-Clark Corp. | 12/02/1985SE |
| K854408 | Adult Absorbent Incontinent BriefEYQ · Traditional | Weyerhaeuser Co. | 11/19/1985SE |
| K853740 | Kay Plus Adult DiaperEYQ · Traditional | Beghin_Say Intl., Inc. | 10/17/1985SE |
| K853079 | Protective Pad for IncontinenceEYQ · Traditional | I.C.D. Industries, Inc. | 08/09/1985SE |
| K852276 | Esteem Incontinent SystemEYQ · Traditional | Bevan Medical, Inc. | 08/07/1985SE |
| K851876 | Prefer Incontinence AidEYQ · Traditional | Rocky Mountain Medical Corp. | 06/12/1985SE |
| K850611 | Attends Incontinent UndergarmentEYQ · Traditional | Procter & Gamble Mfg. Co. | 02/26/1985SE |
| K850154 | Dignity Pant & Absorbent PadsEYQ · Traditional | Convatec, A Division of E.R. Squibb & Sons | 02/14/1985SE |
| K850153 | Adult Dispos. Incontinent PantsEYQ · Traditional | Convatec, A Division of E.R. Squibb & Sons | 02/14/1985SE |
| K845010 | Chesebrough-Pond's Uri-Drain Male Urinary PouchEYQ · Traditional | Chesebrough-Pond'S U.S.A. Co. | 01/15/1985SE |
| K843869 | TranquilityEYQ · Traditional | Principle Business Ent. | 11/16/1984SE |
| K843405 | MolicareEYQ · Traditional | Paul Hartmann Corp. | 10/19/1984SE |
| K843404 | Molinea Incontinent PadEYQ · Traditional | Paul Hartmann Corp. | 10/19/1984SE |
| K843403 | Molinea PantyEYQ · Traditional | Paul Hartmann Corp. | 10/19/1984SE |
| K841953 | Ultra Shield BriefsEYQ · Traditional | Ipco Corp. | 07/19/1984SE |
| K840755 | Minigard Disposable LinersEYQ · Traditional | Ipco Corp. | 04/13/1984SE |
| K840754 | Maxishield Incontinence Care SystemEYQ · Traditional | Ipco Corp. | 04/13/1984SE |
| K840753 | Ambeze Disposable Incontinence PantsEYQ · Traditional | Ipco Corp. | 04/13/1984SE |
| K840679 | Serenity Contoured Absorbent ShieldsEYQ · Traditional | Johnson & Johnson Consumer Products, Inc. | 03/22/1984SE |
| K834359 | Absorbent Incontinent Pads & BriefsEYQ · Traditional | Weyerhaeuser Co. | 03/05/1984SE |
| K840482 | Male Insert SlipEYQ · Traditional | Beghin_Say Intl., Inc. | 02/21/1984SE |
| K834296 | Adult Incontinence BriefEYQ · Traditional | Procter & Gamble Mfg. Co. | 02/04/1984SE |
| K834295 | Adult Incontinence PadEYQ · Traditional | Procter & Gamble Mfg. Co. | 02/04/1984SE |
| K832489 | Conveen Drip Collector/Net PantsEYQ · Traditional | Telcam Medical Devices, Inc. | 09/12/1983SE |
| K821397 | Adult Incontinet BriefEYQ · Traditional | Johnson & Johnson Professionals, Inc. | 05/24/1982SE |
| K820961 | Incontinence Pad or Adult DiaperEYQ · Traditional | Dafoe & Dafoe, Inc. | 04/16/1982SE |
| K810544 | Incontinent Pad & BeltEYQ · Traditional | Principle Business Ent. | 03/11/1981SE |
| K790922 | Disposable Adult DiaperEYQ · Traditional | Fibre Formations, Inc. | 07/30/1979SE |
| K781901 | Kanga PantsEYQ · Traditional | H.A. & J.E. Wood, Inc. | 03/06/1979SE |
| K781930 | Pant Liner, Disp. IncontinentEYQ · Traditional | Fibre Formations, Inc. | 02/01/1979SE |
| K780938 | Super-SorberEYQ · Traditional | Home Healthcare Products, Inc. | 12/15/1978SE |
| K781375 | Comform Absorbant Incontinence PadsEYQ · Traditional | Kimberly-Clark Corp. | 09/20/1978SE |
| K760277 | Underpad Code No. 8453EYQ · Traditional | Johnson & Johnson Professionals, Inc. | 08/11/1976SE |
| K760164 | Underpad, Disposable Polypropy. (Unilux)EYQ · Traditional | Parke-Davis Co. | 07/20/1976SE |