Gards Deodorant Sanitary Napkin
FDA 510(k) K882094 · Hospital Specialty Co.
510(k) numberK882094
Submission
- Device name
- Gards Deodorant Sanitary Napkin
- Applicant
- Hospital Specialty Co.
Cleveland, OH, US - Received
- May 19, 1988
- Decision date
- September 22, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HHL – Pad, Menstrual, Scented, Scented-Deodorized
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5425
- Specialty
- Obstetrics/Gynecology
Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, including those intended as intralabial pads or reusable menstrual pads. These are made with materials that do not meet the requirements for Class 1 per 21 CFR 884.5425(b).
Other 510(k)s with product code HHL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962962 | Deodorant Panty LinerHHL · Traditional | Paragon Trade Brands, Inc. | 10/10/1996SE |
| K962954 | Deodorant Maxi PadHHL · Traditional | Paragon Trade Brands, Inc. | 10/10/1996SE |
| K962953 | Deodorant Panty ShieldHHL · Traditional | Paragon Trade Brands, Inc. | 10/10/1996SE |
| K961119 | Carefree PantylinersHHL · Traditional | Personal Products Co. | 04/17/1996SE |
| K913238 | Always, Unscented Menstrual PadHHL · Traditional | Procter & Gamble Co. | 09/23/1991SE |
| K913237 | Always, Scented/Scented Deodorized Menstrual PadHHL · Traditional | Procter & Gamble Co. | 09/23/1991SE |
| K891473 | Tampax Ultrafit Panty Shields/Dedorant-ModificatioHHL · Traditional | Tambrands, Inc. | 06/07/1989SE |
| K890655 | New Freedom Thin Deodorant Maxi PadsHHL · Traditional | Kimberly-Clark Corp. | 05/01/1989SE |
| K884951 | Tampax Ultrafit Panty Shields, DeodorantHHL · Traditional | Tambrands, Inc. | 01/10/1989SE |
| K884446 | Maxithins Super Pads, DeodorantHHL · Traditional | Tambrands, Inc. | 12/20/1988SE |
More from Tambrands, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K990861 | Wound Dressing/Abd Pad, Model #10810NAD · Traditional | 04/12/1999SE |
| K941099 | Clean-SorbEFQ · Traditional | 09/30/1994SE |
| 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 |
| K822433 | Gards (Unscented, Menstrual Pad)HHD · Traditional | 08/30/1982SE |
Questions and answers
When was Gards Deodorant Sanitary Napkin cleared by the FDA?
Gards Deodorant Sanitary Napkin (K882094) received a 510(k) decision of Substantially Equivalent on September 22, 1988, 126 days after the submission was received.
What is the product code of K882094?
The FDA product code is HHL – Pad, Menstrual, Scented, Scented-Deodorized, a Class II (moderate risk) device regulated under 21 CFR 884.5425.