HHD · Pad, Menstrual, Unscented
Obstetrics/Gynecology · 21 CFR 884.5435 · Class 1
Overview
| Product Code | HHD |
|---|---|
| Device Name | Pad, Menstrual, Unscented |
| Regulation | 21 CFR 884.5435 |
| Device Class | Class 1 |
| Review Panel | Obstetrics/Gynecology |
Identification
An unscented menstrual pad is a device that is a pad made of cellulosic or synthetic material which is used to absorb menstrual or other vaginal discharge. This generic type of device includes sterile unscented menstrual pads used for medically indicated conditions, but does not include menstrual pads treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.
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 § 884.9 only when the device is made of common cellulosic and synthetic material with an established safety profile.
Recent Cleared Devices (20 of 136)
Showing 20 most recent of 136 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K071827 | ALWAYS MENSTRUAL PADS | Procter & Gamble, Inc. | Sep 20, 2007 | SESE |
| K012629 | ALWAYS DUETS | Procter & Gamble Co. | Oct 5, 2001 | SESE |
| K003843 | ENVIVE MINIFORMS | Procter & Gamble Co. | Feb 8, 2001 | SESE |
| K993870 | UNSCENTED INTERLABIAL MENSTRUAL PAD | Procter & Gamble Co. | Jan 18, 2000 | SESE |
| K980395 | GLADRAGS COTTON MENSTRUAL PAD | Keepers!, Inc. | Apr 16, 1998 | SESE |
| K953470 | FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS) | Mediquip, Inc. | Nov 21, 1995 | SESE |
| K953668 | UNSCENTED ULTRATHIN MAXI PAD | Paragon Trade Brands, Inc. | Nov 1, 1995 | SESE |
| K953667 | UNSCENTED CURVED ULTRATHIN MAXI PADS | Paragon Trade Brands, Inc. | Nov 1, 1995 | SESE |
| K953633 | UNSCENTED MENSTRUAL PAD | Tendasoft, Inc. | Nov 1, 1995 | SESE |
| K953553 | UNSCENTED MENSTRAL PAD | Paragon Trade Brands, Inc. | Oct 27, 1995 | SESE |
| K953517 | UNSCENTED MENSTRUAL PAD | Paragon Trade Brands, Inc. | Oct 26, 1995 | SESE |
| K953700 | UNSCENTED CURVED MAXI PAD | Paragon Trade Brands, Inc. | Sep 27, 1995 | SESE |
| K953666 | UNSCENTED MENSTRAL PAD WITH WINGS | Paragon Trade Brands, Inc. | Sep 27, 1995 | SESE |
| K953488 | UNSCENTED MENSTRUAL LINER | Paragon Trade Brands, Inc. | Aug 9, 1995 | SESE |
| K953487 | UNSCENTED MENSTRUAL SHIELD | Paragon Trade Brands, Inc. | Aug 9, 1995 | SESE |
| K951693 | CARESS SANITARY NAPKIN | Sterling U.S.A., Inc. | Jul 25, 1995 | SESE |
| K924502 | REUSABLE MENSTRUAL PAD | Keema and Co. | Nov 30, 1994 | SESE |
| K942814 | SELF SUPER MAXI SNAITARY NAPKINS | Kegan & Kegan, Ltd. | Aug 5, 1994 | SESE |
| K940468 | FEMININE MAXI PADS | B.A. Wholesale, Inc. | May 26, 1994 | SESE |
| K922911 | OPTIONS COMFORT CURVES CLOTH MENSTRUAL PAD SYSTEM | Feminine Options | Apr 22, 1994 | SESE |
Top Applicants
- Kimberly-Clark Corp. — 13 clearances
- Personal Products Co. — 12 clearances
- Procter & Gamble Mfg. Co. — 11 clearances
- Tambrands, Inc. — 10 clearances
- Kao Corp. — 9 clearances
