Tampax Maxithins Pads
FDA 510(k) K810160 · Tampax, Inc.
510(k) numberK810160
Submission
- Device name
- Tampax Maxithins Pads
- Applicant
- Tampax, Inc.
Mchenry, IL, US - Received
- January 22, 1981
- Decision date
- January 28, 1981
- 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 |
| K832974 | Maxithins Unscented Panty ShieldsHHD · Traditional | 10/14/1983SE |
| 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 |
| K802760 | Petal Soft Plastic Applicator TampaxHEB · Traditional | 01/12/1981SE |
| K800777 | Tampax TamponsHEB · Traditional | 05/14/1980SE |
Questions and answers
When was Tampax Maxithins Pads cleared by the FDA?
Tampax Maxithins Pads (K810160) received a 510(k) decision of Substantially Equivalent on January 28, 1981, 6 days after the submission was received.
What is the product code of K810160?
The FDA product code is HHD – Pad, Menstrual, Unscented, a Class I (low risk) device regulated under 21 CFR 884.5435.