Deodorant Panty Liner
FDA 510(k) K962962 · Paragon Trade Brands, Inc.
510(k) numberK962962
Submission
- Device name
- Deodorant Panty Liner
- Applicant
- Paragon Trade Brands, Inc.
Gaffney, SC, US - Received
- July 30, 1996
- Decision date
- October 10, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HHL – Pad, Menstrual, Scented, Scented-Deodorized
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5425
- Specialty
- Obstetrics/Gynecology
Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, including those intended as intralabial pads or reusable menstrual pads. These are made with materials that do not meet the requirements for Class 1 per 21 CFR 884.5425(b).
Other 510(k)s with product code HHL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962954 | Deodorant Maxi PadHHL · Traditional | Paragon Trade Brands, Inc. | 10/10/1996SE |
| K962953 | Deodorant Panty ShieldHHL · Traditional | Paragon Trade Brands, Inc. | 10/10/1996SE |
| K961119 | Carefree PantylinersHHL · Traditional | Personal Products Co. | 04/17/1996SE |
| K913238 | Always, Unscented Menstrual PadHHL · Traditional | Procter & Gamble Co. | 09/23/1991SE |
| K913237 | Always, Scented/Scented Deodorized Menstrual PadHHL · Traditional | Procter & Gamble Co. | 09/23/1991SE |
| K891473 | Tampax Ultrafit Panty Shields/Dedorant-ModificatioHHL · Traditional | Tambrands, Inc. | 06/07/1989SE |
| K890655 | New Freedom Thin Deodorant Maxi PadsHHL · Traditional | Kimberly-Clark Corp. | 05/01/1989SE |
| K884951 | Tampax Ultrafit Panty Shields, DeodorantHHL · Traditional | Tambrands, Inc. | 01/10/1989SE |
| K884446 | Maxithins Super Pads, DeodorantHHL · Traditional | Tambrands, Inc. | 12/20/1988SE |
| K884445 | Maxithins Panty Shields, DeodorantHHL · Traditional | Tambrands, Inc. | 12/05/1988SE |
More from Tambrands, 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 |
| 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 |
| K953700 | Unscented Curved Maxi PadHHD · Traditional | 09/27/1995SE |
Questions and answers
When was Deodorant Panty Liner cleared by the FDA?
Deodorant Panty Liner (K962962) received a 510(k) decision of Substantially Equivalent on October 10, 1996, 72 days after the submission was received.
What is the product code of K962962?
The FDA product code is HHL – Pad, Menstrual, Scented, Scented-Deodorized, a Class II (moderate risk) device regulated under 21 CFR 884.5425.