HHL · Pad, Menstrual, Scented, Scented-Deodorized
Obstetrics/Gynecology · 21 CFR 884.5425 · Class 2
Overview
| Product Code | HHL |
|---|---|
| Device Name | Pad, Menstrual, Scented, Scented-Deodorized |
| Regulation | 21 CFR 884.5425 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
Identification
A scented or scented deodorized menstrual pad is a device that is a pad made of cellulosic or synthetic material which is used to absorb menstrual or other vaginal discharge. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual pad) or for deodorizing purposes (scented deodorized menstrual pad). This generic type of device includes sterile scented menstrual pads used for medically indicated conditions, but does not include menstrual pads treated with added antimicrobial agents or other drugs.
Classification Rationale
(1) Class I (general controls) for menstrual pads made of common cellulosic and synthetic material with an established safety profile. The devices subject to this paragraph (b)(1) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9. This exemption does not include the intralabial pads and reusable menstrual pads.(2) Class II (special controls) for scented or scented deodorized menstrual pads made of materials not described in paragraph (b)(1). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Special Controls
*Classification.* (1) Class I (general controls) for menstrual pads made of common cellulosic and synthetic material with an established safety profile. The devices subject to this paragraph (b)(1) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9. This exemption does not include the intralabial pads and reusable menstrual pads.(2) Class II (special controls) for scented or scented deodorized menstrual pads made of materials not described in paragraph (b)(1). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Recent Cleared Devices (20 of 57)
Showing 20 most recent of 57 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K962962 | DEODORANT PANTY LINER | Paragon Trade Brands, Inc. | Oct 10, 1996 | SESE |
| K962954 | DEODORANT MAXI PAD | Paragon Trade Brands, Inc. | Oct 10, 1996 | SESE |
| K962953 | DEODORANT PANTY SHIELD | Paragon Trade Brands, Inc. | Oct 10, 1996 | SESE |
| K961119 | CAREFREE PANTYLINERS | Personal Products Co. | Apr 17, 1996 | SESE |
| K913238 | ALWAYS, UNSCENTED MENSTRUAL PAD | Procter & Gamble Co. | Sep 23, 1991 | SESE |
| K913237 | ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD | Procter & Gamble Co. | Sep 23, 1991 | SESE |
| K891473 | TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIO | Tambrands, Inc. | Jun 7, 1989 | SESE |
| K890655 | NEW FREEDOM THIN DEODORANT MAXI PADS | Kimberly-Clark Corp. | May 1, 1989 | SESE |
| K884951 | TAMPAX ULTRAFIT PANTY SHIELDS, DEODORANT | Tambrands, Inc. | Jan 10, 1989 | SESE |
| K884446 | MAXITHINS SUPER PADS, DEODORANT | Tambrands, Inc. | Dec 20, 1988 | SESE |
| K884445 | MAXITHINS PANTY SHIELDS, DEODORANT | Tambrands, Inc. | Dec 5, 1988 | SESE |
| K884444 | MAXITHINS REGULAR PADS, DEODORANT | Tambrands, Inc. | Dec 5, 1988 | SESE |
| K884429 | ALWAYS SCENTED OR SCENTED DEODORIZED MENSTRUAL PAD | Procter & Gamble Co. | Dec 2, 1988 | SESE |
| K882094 | GARDS DEODORANT SANITARY NAPKIN | Hospital Specialty Co. | Sep 22, 1988 | SESE |
| K870066 | KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS | Cascades Psh, Inc. | Jun 19, 1987 | SESE |
| K864673 | UNSCENTED MENSTRUAL PAD | Procter & Gamble Mfg. Co. | Jan 21, 1987 | SESE |
| K864187 | KOTEX (R) GOODNITES | Kimberly-Clark Corp. | Dec 11, 1986 | SESE |
| K862675 | MODIFIED DEODORANT MAXITHINS PANTY SHIELDS | Tambrands, Inc. | Aug 18, 1986 | SESE |
| K862678 | MODIFIED REGULAR DEODORANT MAXITHINS PADS | Tambrands, Inc. | Aug 15, 1986 | SESE |
| K862676 | MODIFIED SUPER DEODORANT MAXITHINS PADS | Tambrands, Inc. | Aug 15, 1986 | SESE |
Top Applicants
- Tambrands, Inc. — 11 clearances
- Procter & Gamble Mfg. Co. — 10 clearances
- Kimberly-Clark Corp. — 7 clearances
- Personal Products Co. — 6 clearances
- Int'L Consumer Disposables — 3 clearances
