Modified Protective Garment
FDA 510(k) K861863 · Procter & Gamble Mfg. Co.
510(k) numberK861863
Submission
- Device name
- Modified Protective Garment
- Applicant
- Procter & Gamble Mfg. Co.
Cincinnati, OH, US - Received
- May 15, 1986
- Decision date
- August 11, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EYQ – Garment, Protective, For Incontinence
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5920
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EYQ
| 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 |
More from Hospital Specialty Co.
| 510(k) | Device | Decision |
|---|---|---|
| K873457 | Scented or Scented Deodorized Menstrual PadsHIL · Traditional | 01/19/1988SE |
| K873036 | Attends Incontinent BriefEYQ · Traditional | 01/19/1988SE |
| K864673 | Unscented Menstrual PadHHL · Traditional | 01/21/1987SE |
| K862348 | Single-Use Patient UnderpadKME · Traditional | 07/02/1986SE |
| K860598 | Modified Protective Garment for IncontinentsEYQ · Traditional | 03/05/1986SE |
| K853880 | Attends Dispos. UnderpadKME · Traditional | 10/16/1985SE |
| K853000 | Scented Always PantilinersHHL · Traditional | 09/06/1985SE |
| K852985 | Unscented Always PantilinersHHD · Traditional | 08/29/1985SE |
| K850956 | Always Maxipads - ScentedHHL · Traditional | 05/14/1985SE |
| K850955 | Always Maxipads - UnscentedHHD · Traditional | 05/14/1985SE |
Questions and answers
When was Modified Protective Garment cleared by the FDA?
Modified Protective Garment (K861863) received a 510(k) decision of Substantially Equivalent on August 11, 1986, 88 days after the submission was received.
What is the product code of K861863?
The FDA product code is EYQ – Garment, Protective, For Incontinence, a Class I (low risk) device regulated under 21 CFR 876.5920.