Product Code: EYQ FDA class 1 21 CFR 876.5920

Garment, Protective, For Incontinence

Gastroenterology, Urology

The protective garment for incontinence is a wearable absorbent product designed to contain urinary or fecal leakage in individuals with incontinence, providing skin protection and maintaining dignity and comfort. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is EYQ, regulated under 21 CFR 876.5920 in the Gastroenterology, Urology specialty. This device is GMP exempt.

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510(k)s

FEI Numbers

417

Registration Numbers

418

Unique Applicants

Years Active

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Basic Information

Product Code: EYQ
Device Class: FDA class 1
Regulation Number: 876.5920
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 56 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K950784	DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM	May 03, 1995	Substantially Equivalent	Advanced Bioresearch Assoc.
K932310	KIT PAK INCONTINENT SKIN CARE KIT	Jun 01, 1994	Unknown	Kit Pak, Inc.
K903342	DEODORIZING AND SOUND MUFFLING ANAL PAD	Oct 23, 1990	Substantially Equivalent	Biological Resistance, Inc.
K891686	LIB SYSTEM, BABY/ADULT DIAPER	May 31, 1989	Substantially Equivalent	Intera Corp.
K885185	INTERA SHIELD AND INTERA UNDERGARMENT	Feb 08, 1989	Substantially Equivalent	Intera Corp.
K883895	DRIPRIDE ULTRA INCONTINENT PAD	Jan 30, 1989	Substantially Equivalent	Weyerhaeuser Co.
K883894	DRIPRIDE PROVIDE SLIM	Jan 30, 1989	Substantially Equivalent	Weyerhaeuser Co.
K883787	REUSABLE ADULT INCONTINENT DIAPER	Nov 07, 1988	Substantially Equivalent	Intera Corp.
K882418	DRY COMFORT UNDERGARMENT	Sep 29, 1988	Substantially Equivalent	Health Tec, Inc.
K880454	AT EASE STRESS PAD	Jun 16, 1988	Substantially Equivalent	Hospital Specialty Co.
K880455	AT EASE ADULT DIAPER	Apr 14, 1988	Substantially Equivalent	Hospital Specialty Co.
K880338	CHICOPEE ADULT INCONTINENCE SHIELDS	Mar 31, 1988	Substantially Equivalent	Chicopee, Inc.
K872059	DRIPRIDE PROVIDE ULTRA	Mar 16, 1988	Substantially Equivalent	Weyerhaeuser Co.
K873036	ATTENDS INCONTINENT BRIEF	Jan 19, 1988	Substantially Equivalent	Procter & Gamble Mfg. Co.
K862878	FREE & ACTIVE(TM) ABSORBENT PADS	Nov 19, 1986	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K862877	MALE URINARY STRESS PAD*	Nov 19, 1986	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K861863	MODIFIED PROTECTIVE GARMENT	Aug 11, 1986	Substantially Equivalent	Procter & Gamble Mfg. Co.
K862380	MATTRESS COVER	Jul 28, 1986	Substantially Equivalent	Intera Corp.
K860598	MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS	Mar 05, 1986	Substantially Equivalent	Procter & Gamble Mfg. Co.
K860459	UNITY DISPOSABLE INCONTINENT BRIEF	Feb 26, 1986	Substantially Equivalent	Bevan Medical, Inc.
K854730	DAISY (ABSORBENT INCONTINENCE SHIELD)	Feb 06, 1986	Substantially Equivalent	Lic-Orthion
K854729	ADAM (ABSORBENT INCONTINENCE SHIELD)	Feb 06, 1986	Substantially Equivalent	Lic-Orthion
K854378	DEPEND FITTED BRIEF	Dec 02, 1985	Substantially Equivalent	Kimberly-Clark Corp.
K854408	ADULT ABSORBENT INCONTINENT BRIEF	Nov 19, 1985	Substantially Equivalent	Weyerhaeuser Co.
K853740	KAY PLUS ADULT DIAPER	Oct 17, 1985	Substantially Equivalent	Beghin_Say Intl., Inc.
K853079	PROTECTIVE PAD FOR INCONTINENCE	Aug 09, 1985	Substantially Equivalent	I.C.D. Industries, Inc.
K852276	ESTEEM INCONTINENT SYSTEM	Aug 07, 1985	Substantially Equivalent	Bevan Medical, Inc.
K851876	PREFER INCONTINENCE AID	Jun 12, 1985	Substantially Equivalent	Rocky Mountain Medical Corp.
K850611	ATTENDS INCONTINENT UNDERGARMENT	Feb 26, 1985	Substantially Equivalent	Procter & Gamble Mfg. Co.
K850154	DIGNITY PANT & ABSORBENT PADS	Feb 14, 1985	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K850153	ADULT DISPOS. INCONTINENT PANTS	Feb 14, 1985	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K845010	CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH	Jan 15, 1985	Substantially Equivalent	Chesebrough-Pond'S U.S.A. Co.
K843869	TRANQUILITY	Nov 16, 1984	Substantially Equivalent	Principle Business Ent.
K843405	MOLICARE	Oct 19, 1984	Substantially Equivalent	Paul Hartmann Corp.
K843404	MOLINEA INCONTINENT PAD	Oct 19, 1984	Substantially Equivalent	Paul Hartmann Corp.
K843403	MOLINEA PANTY	Oct 19, 1984	Substantially Equivalent	Paul Hartmann Corp.
K841953	ULTRA SHIELD BRIEFS	Jul 19, 1984	Substantially Equivalent	Ipco Corp.
K840755	MINIGARD DISPOSABLE LINERS	Apr 13, 1984	Substantially Equivalent	Ipco Corp.
K840754	MAXISHIELD INCONTINENCE CARE SYSTEM	Apr 13, 1984	Substantially Equivalent	Ipco Corp.
K840753	AMBEZE DISPOSABLE INCONTINENCE PANTS	Apr 13, 1984	Substantially Equivalent	Ipco Corp.
K840679	SERENITY CONTOURED ABSORBENT SHIELDS	Mar 22, 1984	Substantially Equivalent	Johnson & Johnson Consumer Products, Inc.
K834359	ABSORBENT INCONTINENT PADS & BRIEFS	Mar 05, 1984	Substantially Equivalent	Weyerhaeuser Co.
K840482	MALE INSERT SLIP	Feb 21, 1984	Substantially Equivalent	Beghin_Say Intl., Inc.
K834296	ADULT INCONTINENCE BRIEF	Feb 04, 1984	Substantially Equivalent	Procter & Gamble Mfg. Co.
K834295	ADULT INCONTINENCE PAD	Feb 04, 1984	Substantially Equivalent	Procter & Gamble Mfg. Co.
K832489	CONVEEN DRIP COLLECTOR/NET PANTS	Sep 12, 1983	Substantially Equivalent	Telcam Medical Devices, Inc.
K821397	ADULT INCONTINET BRIEF	May 24, 1982	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K820961	INCONTINENCE PAD OR ADULT DIAPER	Apr 16, 1982	Substantially Equivalent	Dafoe & Dafoe, Inc.
K810544	INCONTINENT PAD & BELT	Mar 11, 1981	Substantially Equivalent	Principle Business Ent.
K790922	DISPOSABLE ADULT DIAPER	Jul 30, 1979	Substantially Equivalent	Fibre Formations, Inc.
K781901	KANGA PANTS	Mar 06, 1979	Substantially Equivalent	H.A. & J.E. Wood, Inc.
K781930	PANT LINER, DISP. INCONTINENT	Feb 01, 1979	Substantially Equivalent	Fibre Formations, Inc.
K780938	SUPER-SORBER	Dec 15, 1978	Substantially Equivalent	Home Healthcare Products, Inc.
K781375	COMFORM ABSORBANT INCONTINENCE PADS	Sep 20, 1978	Substantially Equivalent	Kimberly-Clark Corp.
K760277	UNDERPAD CODE NO. 8453	Aug 11, 1976	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K760164	UNDERPAD, DISPOSABLE POLYPROPY. (UNILUX)	Jul 20, 1976	Substantially Equivalent	Parke-Davis Co.