EYQ · Garment, Protective, For Incontinence
Gastroenterology, Urology · 21 CFR 876.5920 · Class 1
Overview
| Product Code | EYQ |
|---|---|
| Device Name | Garment, Protective, For Incontinence |
| Regulation | 21 CFR 876.5920 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
| GMP Exempt | Yes |
Identification
A protective garment for incontinence is a device that consists of absorbent padding and a fluid barrier and that is intended to protect an incontinent patient's garment from the patient's excreta. This generic type of device does not include diapers for infants.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 56)
Showing 20 most recent of 56 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K950784 | DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM | Advanced Bioresearch Assoc. | May 3, 1995 | SESE |
| K932310 | KIT PAK INCONTINENT SKIN CARE KIT | Kit Pak, Inc. | Jun 1, 1994 | SEKD |
| K903342 | DEODORIZING AND SOUND MUFFLING ANAL PAD | Biological Resistance, Inc. | Oct 23, 1990 | SESE |
| K891686 | LIB SYSTEM, BABY/ADULT DIAPER | Intera Corp. | May 31, 1989 | SESE |
| K885185 | INTERA SHIELD AND INTERA UNDERGARMENT | Intera Corp. | Feb 8, 1989 | SESE |
| K883895 | DRIPRIDE ULTRA INCONTINENT PAD | Weyerhaeuser Co. | Jan 30, 1989 | SESE |
| K883894 | DRIPRIDE PROVIDE SLIM | Weyerhaeuser Co. | Jan 30, 1989 | SESE |
| K883787 | REUSABLE ADULT INCONTINENT DIAPER | Intera Corp. | Nov 7, 1988 | SESE |
| K882418 | DRY COMFORT UNDERGARMENT | Health Tec, Inc. | Sep 29, 1988 | SESE |
| K880454 | AT EASE STRESS PAD | Hospital Specialty Co. | Jun 16, 1988 | SESE |
| K880455 | AT EASE ADULT DIAPER | Hospital Specialty Co. | Apr 14, 1988 | SESE |
| K880338 | CHICOPEE ADULT INCONTINENCE SHIELDS | Chicopee, Inc. | Mar 31, 1988 | SESE |
| K872059 | DRIPRIDE PROVIDE ULTRA | Weyerhaeuser Co. | Mar 16, 1988 | SESE |
| K873036 | ATTENDS INCONTINENT BRIEF | Procter & Gamble Mfg. Co. | Jan 19, 1988 | SESE |
| K862878 | FREE & ACTIVE(TM) ABSORBENT PADS | Convatec, A Division of E.R. Squibb & Sons | Nov 19, 1986 | SESE |
| K862877 | MALE URINARY STRESS PAD* | Convatec, A Division of E.R. Squibb & Sons | Nov 19, 1986 | SESE |
| K861863 | MODIFIED PROTECTIVE GARMENT | Procter & Gamble Mfg. Co. | Aug 11, 1986 | SESE |
| K862380 | MATTRESS COVER | Intera Corp. | Jul 28, 1986 | SESE |
| K860598 | MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS | Procter & Gamble Mfg. Co. | Mar 5, 1986 | SESE |
| K860459 | UNITY DISPOSABLE INCONTINENT BRIEF | Bevan Medical, Inc. | Feb 26, 1986 | SESE |
Top Applicants
- Procter & Gamble Mfg. Co. — 6 clearances
- Weyerhaeuser Co. — 5 clearances
- Convatec, A Division of E.R. Squibb & Sons — 4 clearances
- Intera Corp. — 4 clearances
- Ipco Corp. — 4 clearances
