Carefree Pantyliners
FDA 510(k) K961119 · Personal Products Co.
510(k) numberK961119
Submission
- Device name
- Carefree Pantyliners
- Applicant
- Personal Products Co.
Skillman, NJ, US - Received
- March 21, 1996
- Decision date
- April 17, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K962953 | Deodorant Panty ShieldHHL · Traditional | Paragon Trade Brands, Inc. | 10/10/1996SE |
| 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 |
|---|---|---|
| K070545 | K-Y Brand Warming LiquidNUC · Special | 03/23/2007SE |
| K062796 | K-Y Brand IntrigueNUC · Traditional | 12/08/2006SE |
| K010365 | Ortho Control Female Urinary Control DeviceMNG · Traditional | 04/30/2001SE |
| K990536 | O.B. TamponHEB · Traditional | 08/31/1999SE |
| K991118 | O.B. Applicator Tampons, O.B. TamponsHEB · Traditional | 06/29/1999SE |
| K974629 | O.B. Applicator and Non-Applicator TamponsHEB · Traditional | 02/10/1998SE |
| K971589 | Reach Antibacterial ToothbrushEFW · Traditional | 07/24/1997SE |
| K970954 | O.B. Applicator TamponsHEB · Traditional | 06/10/1997SE |
| K953638 | O.B. Applicator TamponsHIL · Traditional | 10/20/1995SE |
| K941863 | O.B. TamponHEB · Traditional | 06/27/1994SE |
Questions and answers
When was Carefree Pantyliners cleared by the FDA?
Carefree Pantyliners (K961119) received a 510(k) decision of Substantially Equivalent on April 17, 1996, 27 days after the submission was received.
What is the product code of K961119?
The FDA product code is HHL – Pad, Menstrual, Scented, Scented-Deodorized, a Class II (moderate risk) device regulated under 21 CFR 884.5425.