Gladrags Cotton Menstrual Pad
FDA 510(k) K980395 · Keepers!, Inc.
510(k) numberK980395
Submission
- Device name
- Gladrags Cotton Menstrual Pad
- Applicant
- Keepers!, Inc.
Portland, OR, US - Received
- February 2, 1998
- Decision date
- April 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K953517 | Unscented Menstrual PadHHD · Traditional | Paragon Trade Brands, Inc. | 10/26/1995SE |
Questions and answers
When was Gladrags Cotton Menstrual Pad cleared by the FDA?
Gladrags Cotton Menstrual Pad (K980395) received a 510(k) decision of Substantially Equivalent on April 16, 1998, 73 days after the submission was received.
What is the product code of K980395?
The FDA product code is HHD – Pad, Menstrual, Unscented, a Class I (low risk) device regulated under 21 CFR 884.5435.