Maxithins Unscented Panty Shields
FDA 510(k) K832974 · Tampax, Inc.
510(k) numberK832974
Submission
- Device name
- Maxithins Unscented Panty Shields
- Applicant
- Tampax, Inc.
Mchenry, IL, US - Received
- September 1, 1983
- Decision date
- October 14, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HHD – Pad, Menstrual, Unscented
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.5435
- Specialty
- Obstetrics/Gynecology
An unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic and synthetic material with an established safety profile.
Other 510(k)s with product code HHD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K071827 | Always Menstrual PadsHHD · Traditional | Procter & Gamble, Inc. | 09/20/2007SE |
| K012629 | Always DuetsHHD · Traditional | Procter & Gamble Co. | 10/05/2001SE |
| K003843 | Envive MiniformsHHD · Traditional | Procter & Gamble Co. | 02/08/2001SE |
| K993870 | Unscented Interlabial Menstrual PadHHD · Traditional | Procter & Gamble Co. | 01/18/2000SE |
| K980395 | Gladrags Cotton Menstrual PadHHD · Traditional | Keepers!, Inc. | 04/16/1998SE |
| K953470 | Flushies Flushable/Biodegradable Menstrual Pads/Napkins (Ultra Thins)HHD · Traditional | Mediquip, Inc. | 11/21/1995SE |
| K953668 | Unscented Ultrathin Maxi PadHHD · Traditional | Paragon Trade Brands, Inc. | 11/01/1995SE |
| K953667 | Unscented Curved Ultrathin Maxi PadsHHD · Traditional | Paragon Trade Brands, Inc. | 11/01/1995SE |
| K953633 | Unscented Menstrual PadHHD · Traditional | Tendasoft, Inc. | 11/01/1995SE |
| K953553 | Unscented Menstral PadHHD · Traditional | Paragon Trade Brands, Inc. | 10/27/1995SE |
More from Paragon Trade Brands, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K832973 | Tampax Super Deodorant MaxithinsHHL · Traditional | 11/28/1983SE |
| K832972 | Regular Deodorant Maxithins PadsHHL · Traditional | 11/28/1983SE |
| K832971 | Deodorant Maxithins Panty ShieldHHL · Traditional | 11/28/1983SE |
| K821800 | Regular Maxithins Pads & Super MaxithinsHHD · Traditional | 06/25/1982SE |
| K820174 | Tampax TamponsHEB · Traditional | 03/18/1982SE |
| K813642 | Petal Soft Plastic Applicator TampaxHEB · Traditional | 01/25/1982SE |
| K810143 | Tampax Deodorant TamponsHIL · Traditional | 03/04/1981SE |
| K810160 | Tampax Maxithins PadsHHD · Traditional | 01/28/1981SE |
| K802760 | Petal Soft Plastic Applicator TampaxHEB · Traditional | 01/12/1981SE |
| K800777 | Tampax TamponsHEB · Traditional | 05/14/1980SE |
Questions and answers
When was Maxithins Unscented Panty Shields cleared by the FDA?
Maxithins Unscented Panty Shields (K832974) received a 510(k) decision of Substantially Equivalent on October 14, 1983, 43 days after the submission was received.
What is the product code of K832974?
The FDA product code is HHD – Pad, Menstrual, Unscented, a Class I (low risk) device regulated under 21 CFR 884.5435.