Unscented Menstral Pad with Wings
FDA 510(k) K953666 · Paragon Trade Brands, Inc.
510(k) numberK953666
Submission
- Device name
- Unscented Menstral Pad with Wings
- Applicant
- Paragon Trade Brands, Inc.
Federal Way, WA, US - Received
- August 7, 1995
- Decision date
- September 27, 1995
- 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 |
| 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 |
|---|---|---|
| K983381 | Various Trade Tampons Sold Under Private LabelsHEB · Traditional | 10/19/1998SE |
| K981953 | Various Trade Tampons Sold Under Private LabelsHEB · Traditional | 08/18/1998SE |
| K962962 | Deodorant Panty LinerHHL · Traditional | 10/10/1996SE |
| K962954 | Deodorant Maxi PadHHL · Traditional | 10/10/1996SE |
| K962953 | Deodorant Panty ShieldHHL · Traditional | 10/10/1996SE |
| K953333 | Menstrual TamponHEB · Traditional | 12/06/1995SE |
| K953668 | Unscented Ultrathin Maxi PadHHD · Traditional | 11/01/1995SE |
| K953667 | Unscented Curved Ultrathin Maxi PadsHHD · Traditional | 11/01/1995SE |
| K953553 | Unscented Menstral PadHHD · Traditional | 10/27/1995SE |
| K953517 | Unscented Menstrual PadHHD · Traditional | 10/26/1995SE |
Questions and answers
When was Unscented Menstral Pad with Wings cleared by the FDA?
Unscented Menstral Pad with Wings (K953666) received a 510(k) decision of Substantially Equivalent on September 27, 1995, 51 days after the submission was received.
What is the product code of K953666?
The FDA product code is HHD – Pad, Menstrual, Unscented, a Class I (low risk) device regulated under 21 CFR 884.5435.