← Product Code [HEB](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB) · K963034

# FEMTEX GENTLE TOUCH TAMPONS (K963034)

_First Quality Hygienic, Inc. · HEB · Nov 1, 1996 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB/K963034

## Device Facts

- **Applicant:** First Quality Hygienic, Inc.
- **Product Code:** [HEB](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB.md)
- **Decision Date:** Nov 1, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.5470
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Indications for Use

Femtex Gentle Touch tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

## Device Story

Menstrual tampons; rayon and cotton construction; cotton cord and sewing thread. Used for absorption of menstrual fluid. Inserted into vagina. Available in regular, super, and super plus absorbencies. Intended for use by females during menstruation.

## Clinical Evidence

Bench testing only. Biocompatibility testing (irritation, sensitization, vaginal irritation) and Syngyna absorbency testing performed. Results demonstrate safety and effectiveness equivalent to legally marketed tampons.

## Technological Characteristics

Materials: rayon, cotton, cotton cord, sewing thread. Absorbency tested via standard Syngyna method. No electronic or software components.

## Regulatory Identification

An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.

## Predicate Devices

- Femtex tampons with applicators

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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NOV 1 1996
K963034

# 510K SUMMARY

Device Name: Femtex Gentle Touch Tampons

Legally marketed device: These Femtex Gentle Touch Tampons are substantially equivalent to legally marketed Femtex tampons with applicators.

Device description: Femtex Gentle Touch Tampons are menstrual tampons used to absorb menstrual fluid. Femtex Gentle Touch Tampons will be provided with 3 absorbencies, regular, super and super plus.

Femtex Gentle Touch Tampons are made from rayon and, cotton cord and sewing thread.

The material used in Femtex Gentle Touch tampons are similar to those used in other legally marketed tampons.

Intended Use: Femtex Gentle Touch tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

Assessment of Performance Standards: Not Applicable

Non-Clinical Testing: Biocompatibility testing of the Femtex Gentle Touch Tampons was carried out. The results of these tests demonstrate that Femtex Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons. Standard Syngyna testing confirmed the absorbency of Femtex Tampons. In addition to the review of existing toxicological data in the public literature, the following tests were conducted relevant to the safety of Femtex tampons.

- irritation testing
- sensitization testing
- vaginal irritation testing

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB/K963034](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB/K963034)

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