Gards Deodorant Sanitary Napkin
510(k) K882094
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK882094 | Date22 Sep 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HHL
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5425
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Gards Deodorant Sanitary Napkin is a scented, deodorized menstrual pad designed for feminine hygiene. Classified as a menstrual pad under FDA nomenclature, it is intended to absorb menstrual flow while providing odor control through integrated deodorizing properties. This product falls under the category of scented-deodorized menstrual products, offering a solution for menstrual management with added comfort.
This device is supplied as a single-use, non-sterile product and is regulated under FDA 510(k) clearance (K882094) with a classification of Class II. It is intended for use in obstetrics/gynecology settings and is distributed under the product code HHL. The device was cleared through a traditional 510(k) review process, with a decision date of September 22, 1988, and is not intended for MRI use or reusable applications. Storage and handling follow standard hygiene practices for menstrual products.
Other devices from Hospital Specialty Co.
Questions
AI-generated answers, 1 Oct 2026
What is the Gards Deodorant Sanitary Napkin designed for?
The Gards Deodorant Sanitary Napkin is specifically designed for feminine hygiene during menstruation. It functions as a menstrual pad to absorb menstrual flow while incorporating deodorizing properties to help control odor, providing added comfort and confidence for users.
Is the Gards Deodorant Sanitary Napkin sterile?
No, the Gards Deodorant Sanitary Napkin is classified as a non-sterile product. It is intended for single-use and follows standard hygiene practices for menstrual products, which do not require sterility.
How is the Gards Deodorant Sanitary Napkin regulated?
This product is regulated under the FDA’s 510(k) clearance process, specifically under the classification of Class II. It was cleared through a traditional 510(k) review by the Obstetrics/Gynecology advisory committee on September 22, 1988, with the clearance number K882094. It is not intended for MRI use or reusable applications.
What are the available sizes or models for the Gards Deodorant Sanitary Napkin?
The Gards Deodorant Sanitary Napkin is available in multiple registration numbers (e.g., 3019469637, 3017907679, etc.), which likely correspond to different sizes or variations of the product. These registration numbers are tracked under the product code HHL and are intended for use in obstetrics/gynecology settings.
How should the Gards Deodorant Sanitary Napkin be stored?
The Gards Deodorant Sanitary Napkin should be stored according to standard hygiene practices for menstrual products. This includes keeping it in a cool, dry place, away from direct sunlight or extreme temperatures, and ensuring the packaging remains intact until use to maintain its effectiveness and hygiene.