← Product Code [HEB](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB) · K971228

# FEMTEX 100% COTTON TAMPONS (K971228)

_Regu-Tech Assoc., Inc. · HEB · Apr 9, 1997 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB/K971228

## Device Facts

- **Applicant:** Regu-Tech Assoc., Inc.
- **Product Code:** [HEB](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB.md)
- **Decision Date:** Apr 9, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.5470
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Indications for Use

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

## Device Story

Menstrual tampon; cotton construction with cotton cord and sewing thread; regular and super absorbencies; inserted into vagina to absorb menstrual fluid; intended for consumer self-use.

## Clinical Evidence

Bench testing only. Biocompatibility testing (cytotoxicity) and Syngyna absorbency testing performed. Review of existing toxicological data from public literature.

## Technological Characteristics

Materials: 100% cotton, cotton cord, sewing thread. Form factor: menstrual tampon. Absorbency levels: regular, super.

## 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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# 510K SUMMARY

APR - 9 1997

Device Name: Femtex 100% Cotton Tampons

Legally marketed device: These Femtex 100% Cotton Tampons are substantially equivalent to legally marketed Femtex tampons with applicators.

Device description: Femtex 100% Cotton Tampons are menstrual tampons used to absorb menstrual fluid. Femtex Tampons will be provided with 2 absorbencies, regular, and super.

Femtex 100% Cotton Tampons are made from cotton and, cotton cord and sewing thread.

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

Intended Use: Femtex 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 a cotton tampon which was applicable to the Femtex Tampons was carried out. The results of these tests demonstrate that cotton tamons are equivalent in terms of safety and effectiveness to legally marketed tampons. Standard Syngyna testing confirmed the absorbency of Femtex 100% Cotton Tampons. In addition to the review of existing toxicological data in the public literature, the following tests were conducted relevant to the safety of cotton tampons.

♦ cytotoxicity testing

***

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB/K971228](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB/K971228)

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