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Gards Deodorant Sanitary Napkin

by Hospital Specialty Co.

510(k) K882094

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK882094 Date22 Sep 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.