Unscented Menstrual Pads
FDA 510(k) K812577 · Weyerhaeuser Co.
510(k) numberK812577
Submission
- Device name
- Unscented Menstrual Pads
- Applicant
- Weyerhaeuser Co.
Mchenry, IL, US - Received
- September 9, 1981
- Decision date
- October 19, 1981
- 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 |
|---|---|---|
| K883895 | Dripride Ultra Incontinent PadEYQ · Traditional | 01/30/1989SE |
| K883894 | Dripride Provide SlimEYQ · Traditional | 01/30/1989SE |
| K881859 | Dripride Disposable UnderpadKME · Traditional | 06/03/1988SE |
| K872059 | Dripride Provide UltraEYQ · Traditional | 03/16/1988SE |
| K871725 | Dripride Disposable UnderpadsKME · Traditional | 05/15/1987SE |
| K854408 | Adult Absorbent Incontinent BriefEYQ · Traditional | 11/19/1985SE |
| K834359 | Absorbent Incontinent Pads & BriefsEYQ · Traditional | 03/05/1984SE |
| K831593 | Maxi ShieldsHHD · Traditional | 08/12/1983SE |
| K830224 | Unscented Panty ShieldsHHD · Traditional | 02/08/1983SE |
Questions and answers
When was Unscented Menstrual Pads cleared by the FDA?
Unscented Menstrual Pads (K812577) received a 510(k) decision of Substantially Equivalent on October 19, 1981, 40 days after the submission was received.
What is the product code of K812577?
The FDA product code is HHD – Pad, Menstrual, Unscented, a Class I (low risk) device regulated under 21 CFR 884.5435.