HHL — Pad, Menstrual, Scented, Scented-Deodorized Class II
FDA product code HHL covers "Pad, Menstrual, Scented, Scented-Deodorized", a Class II medical device regulated under 21 CFR 884.5425. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HHL
- Device Class
- Class II
- Regulation Number
- 884.5425
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K962953 | paragon trade brands | DEODORANT PANTY SHIELD | October 10, 1996 |
| K962962 | paragon trade brands | DEODORANT PANTY LINER | October 10, 1996 |
| K962954 | paragon trade brands | DEODORANT MAXI PAD | October 10, 1996 |
| K961119 | personal products | CAREFREE PANTYLINERS | April 17, 1996 |
| K913237 | procter and gamble | ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD | September 23, 1991 |
| K913238 | procter and gamble | ALWAYS, UNSCENTED MENSTRUAL PAD | September 23, 1991 |
| K891473 | tambrands | TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIO | June 7, 1989 |
| K890655 | kimberly-clark | NEW FREEDOM THIN DEODORANT MAXI PADS | May 1, 1989 |
| K884951 | tambrands | TAMPAX ULTRAFIT PANTY SHIELDS, DEODORANT | January 10, 1989 |
| K884446 | tambrands | MAXITHINS SUPER PADS, DEODORANT | December 20, 1988 |
| K884444 | tambrands | MAXITHINS REGULAR PADS, DEODORANT | December 5, 1988 |
| K884445 | tambrands | MAXITHINS PANTY SHIELDS, DEODORANT | December 5, 1988 |
| K884429 | procter and gamble | ALWAYS SCENTED OR SCENTED DEODORIZED MENSTRUAL PAD | December 2, 1988 |
| K882094 | hospital specialty | GARDS DEODORANT SANITARY NAPKIN | September 22, 1988 |
| K870066 | cascades psh | KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS | June 19, 1987 |
| K864673 | procter and gamble mfg | UNSCENTED MENSTRUAL PAD | January 21, 1987 |
| K864187 | kimberly-clark | KOTEX (R) GOODNITES | December 11, 1986 |
| K862675 | tambrands | MODIFIED DEODORANT MAXITHINS PANTY SHIELDS | August 18, 1986 |
| K862678 | tambrands | MODIFIED REGULAR DEODORANT MAXITHINS PADS | August 15, 1986 |
| K862676 | tambrands | MODIFIED SUPER DEODORANT MAXITHINS PADS | August 15, 1986 |