Safe & Soft Mini Pads & Maxi Pads
FDA 510(k) K842836 · Ipco Corp.
510(k) numberK842836
Submission
- Device name
- Safe & Soft Mini Pads & Maxi Pads
- Applicant
- Ipco Corp.
White Plains, NY, US - Received
- July 20, 1984
- Decision date
- October 15, 1984
- 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 |
|---|---|---|
| K871270 | Perform Denture Base ResinEBF · Traditional | 05/29/1987SE |
| K850666 | Strobex Ultron Electrosurge-Dental UnitEKZ · Traditional | 05/29/1985SE |
| K850906 | Tactile Plus Dental ElevatorsEMJ · Traditional | 04/12/1985SE |
| K842837 | Safe & Soft Maxi ShiledsHHD · Traditional | 10/15/1984SE |
| K842838 | Safe & Soft Panty ShieldsHHD · Traditional | 10/05/1984SE |
| K841953 | Ultra Shield BriefsEYQ · Traditional | 07/19/1984SE |
| K840755 | Minigard Disposable LinersEYQ · Traditional | 04/13/1984SE |
| K840754 | Maxishield Incontinence Care SystemEYQ · Traditional | 04/13/1984SE |
| K840753 | Ambeze Disposable Incontinence PantsEYQ · Traditional | 04/13/1984SE |
| K800293 | File, Pulp CanalEKS · Traditional | 02/19/1980SE |
Questions and answers
When was Safe & Soft Mini Pads & Maxi Pads cleared by the FDA?
Safe & Soft Mini Pads & Maxi Pads (K842836) received a 510(k) decision of Substantially Equivalent on October 15, 1984, 87 days after the submission was received.
What is the product code of K842836?
The FDA product code is HHD – Pad, Menstrual, Unscented, a Class I (low risk) device regulated under 21 CFR 884.5435.