Pads, Mini, Maxi
FDA 510(k) K782112 · Intl. Playtex, Inc.
510(k) numberK782112
Submission
- Device name
- Pads, Mini, Maxi
- Applicant
- Intl. Playtex, Inc.
Walker, MI, US - Received
- December 18, 1978
- Decision date
- January 8, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HHD – Pad, Menstrual, Unscented
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.5435
- Specialty
- Obstetrics/Gynecology
An unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic and synthetic material with an established safety profile.
Other 510(k)s with product code HHD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K071827 | Always Menstrual PadsHHD · Traditional | Procter & Gamble, Inc. | 09/20/2007SE |
| K012629 | Always DuetsHHD · Traditional | Procter & Gamble Co. | 10/05/2001SE |
| K003843 | Envive MiniformsHHD · Traditional | Procter & Gamble Co. | 02/08/2001SE |
| K993870 | Unscented Interlabial Menstrual PadHHD · Traditional | Procter & Gamble Co. | 01/18/2000SE |
| K980395 | Gladrags Cotton Menstrual PadHHD · Traditional | Keepers!, Inc. | 04/16/1998SE |
| K953470 | Flushies Flushable/Biodegradable Menstrual Pads/Napkins (Ultra Thins)HHD · Traditional | Mediquip, Inc. | 11/21/1995SE |
| K953668 | Unscented Ultrathin Maxi PadHHD · Traditional | Paragon Trade Brands, Inc. | 11/01/1995SE |
| K953667 | Unscented Curved Ultrathin Maxi PadsHHD · Traditional | Paragon Trade Brands, Inc. | 11/01/1995SE |
| K953633 | Unscented Menstrual PadHHD · Traditional | Tendasoft, Inc. | 11/01/1995SE |
| K953553 | Unscented Menstral PadHHD · Traditional | Paragon Trade Brands, Inc. | 10/27/1995SE |
More from Paragon Trade Brands, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K871197 | Playtex Tampons and Deodorant TamponsHIL · Traditional | 05/12/1987SE |
| K861738 | Playtex TamponsHIL · Traditional | 07/22/1986SE |
| K854258 | Playtex Light'N Gentle Unscented/Deodorant/Mini TaHIL · Traditional | 11/21/1985SE |
| K852063 | Playtex Slender Reg. Tampons & Deodorant TamponsHEB · Traditional | 05/22/1985SE |
| K851356 | Playtex Super Tampons & Super Deodorant TamponsHEB · Traditional | 04/12/1985SE |
| K851355 | Playtex Super Plus Tampons & Deodorant TamponsHEB · Traditional | 04/12/1985SE |
| K782111 | Pads, Mini, Maxi DeodorantHHL · Traditional | 01/08/1979SE |
| K760425 | Tampon, Playtex 2 Version aHIL · Traditional | 09/13/1976SE |
| K760426 | Tampon, Playtex 2 Version BHIL · Traditional | 08/26/1976SE |
Questions and answers
When was Pads, Mini, Maxi cleared by the FDA?
Pads, Mini, Maxi (K782112) received a 510(k) decision of Substantially Equivalent on January 8, 1979, 21 days after the submission was received.
What is the product code of K782112?
The FDA product code is HHD – Pad, Menstrual, Unscented, a Class I (low risk) device regulated under 21 CFR 884.5435.