Promise Absorbent Protective Pad
FDA 510(k) K900421 · Scott Health Care
510(k) numberK900421
Submission
- Device name
- Promise Absorbent Protective Pad
- Applicant
- Scott Health Care
Philadelphia, PA, US - Received
- January 30, 1990
- Decision date
- June 6, 1990
- 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 |
|---|---|---|
| K954275 | Mepore Plus (9X15CM)KMF · Traditional | 12/27/1995SE |
| K954274 | Mepore (6X7)KMF · Traditional | 12/19/1995SE |
| K945206 | Alldress Multi Layered Wound DressingKMF · Traditional | 01/12/1995SE |
| K932743 | Mefix(R) Adhesive Fabric for Dressing FixationKGX · Traditional | 09/10/1993SE |
| K905439 | Hypergel Protective Wound GelKMF · Traditional | 05/29/1991SE |
| K910857 | Alldress Multi Layered Wound DressingNAB · Traditional | 04/12/1991SE |
| K905438 | Normlgel Protective Wound GelFRO · Traditional | 04/01/1991SE |
| K897142 | Mesalt Sterile DressingFRO · Traditional | 03/27/1990SE |
Questions and answers
When was Promise Absorbent Protective Pad cleared by the FDA?
Promise Absorbent Protective Pad (K900421) received a 510(k) decision of Substantially Equivalent on June 6, 1990, 127 days after the submission was received.
What is the product code of K900421?
The FDA product code is HHD – Pad, Menstrual, Unscented, a Class I (low risk) device regulated under 21 CFR 884.5435.