Deodorant Panty Shield
FDA 510(k) K962953 · Paragon Trade Brands, Inc.
510(k) numberK962953
Submission
- Device name
- Deodorant Panty Shield
- 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 |
|---|---|---|---|
| K962962 | Deodorant Panty LinerHHL · Traditional | Paragon Trade Brands, Inc. | 10/10/1996SE |
| K962954 | Deodorant Maxi PadHHL · 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 |
| K962962 | Deodorant Panty LinerHHL · Traditional | 10/10/1996SE |
| K962954 | Deodorant Maxi PadHHL · 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 Shield cleared by the FDA?
Deodorant Panty Shield (K962953) 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 K962953?
The FDA product code is HHL – Pad, Menstrual, Scented, Scented-Deodorized, a Class II (moderate risk) device regulated under 21 CFR 884.5425.