Breathable Mini-Shield-Private Label
FDA 510(k) K843602 · I.C.D. Industries, Inc.
510(k) numberK843602
Submission
- Device name
- Breathable Mini-Shield-Private Label
- Applicant
- I.C.D. Industries, Inc.
Mchenry, IL, US - Received
- September 12, 1984
- Decision date
- October 5, 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 |
|---|---|---|
| K860294 | Hospital Tabbed Napkins Super Belted Feminine NapkHHD · Traditional | 03/13/1986SE |
| K853079 | Protective Pad for IncontinenceEYQ · Traditional | 08/09/1985SE |
| K844975 | Scented Breathable Mini-Shield Private Label BrandHHL · Traditional | 02/25/1985SE |
| K843886 | Scented Breathable Private Label Mini-ShHHL · Traditional | 10/25/1984SE |
| K820288 | Mini Shields Menstrual PadsHHD · Traditional | 03/05/1982SE |
| K820287 | Maxi Shields Menstrual PadsHHD · Traditional | 03/05/1982SE |
| K813252 | Unscented Menstrual Pads-Mini PadsHHD · Traditional | 12/14/1981SE |
| K813251 | Unscented Menstrual Pads-Maxi PadsHHD · Traditional | 12/14/1981SE |
Questions and answers
When was Breathable Mini-Shield-Private Label cleared by the FDA?
Breathable Mini-Shield-Private Label (K843602) received a 510(k) decision of Substantially Equivalent on October 5, 1984, 23 days after the submission was received.
What is the product code of K843602?
The FDA product code is HHD – Pad, Menstrual, Unscented, a Class I (low risk) device regulated under 21 CFR 884.5435.