Gards (Unscented, Menstrual Pad)
FDA 510(k) K822433 · Hospital Specialty Co.
510(k) numberK822433
Submission
- Device name
- Gards (Unscented, Menstrual Pad)
- Applicant
- Hospital Specialty Co.
Mchenry, IL, US - Received
- August 12, 1982
- Decision date
- August 30, 1982
- 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 |
|---|---|---|
| K990861 | Wound Dressing/Abd Pad, Model #10810NAD · Traditional | 04/12/1999SE |
| K941099 | Clean-SorbEFQ · Traditional | 09/30/1994SE |
| K882094 | Gards Deodorant Sanitary NapkinHHL · Traditional | 09/22/1988SE |
| K880454 | At Ease Stress PadEYQ · Traditional | 06/16/1988SE |
| K880455 | At Ease Adult DiaperEYQ · Traditional | 04/14/1988SE |
| K822242 | Sanitary/Ob NapkinsHHD · Traditional | 09/09/1982SE |
Questions and answers
When was Gards (Unscented, Menstrual Pad) cleared by the FDA?
Gards (Unscented, Menstrual Pad) (K822433) received a 510(k) decision of Substantially Equivalent on August 30, 1982, 18 days after the submission was received.
What is the product code of K822433?
The FDA product code is HHD – Pad, Menstrual, Unscented, a Class I (low risk) device regulated under 21 CFR 884.5435.