← Product Code [HEB](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB) · K970232

# FEMTEX 100% COTTON DENTLE TOUCH TAMPONS (K970232)

_Regu-Tech Assoc., Inc. · HEB · Mar 21, 1997 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB/K970232

## 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:** Mar 21, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.5470
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Indications for Use

Femtex 100% Cotton Gentle Touch tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

## Device Story

Menstrual tampons; inserted into vagina to absorb menstrual fluid. Composed of cotton absorbent, cotton cord, and cotton sewing thread. Available in regular and super absorbencies. Used by patients for menstrual hygiene management.

## Clinical Evidence

Bench testing only. Biocompatibility testing performed including irritation, cytotoxicity, sensitization, and vaginal irritation testing. Syngyna testing conducted to confirm absorbency performance. Results demonstrate safety and effectiveness equivalent to legally marketed tampons.

## Technological Characteristics

Materials: 100% cotton absorbent, cotton cord, cotton sewing thread. Form factor: tampon with applicator. Absorbency: regular and super. 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 Gentle Touch tampons

## 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.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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K970232

MAR 21 1997

# 510K SUMMARY

Device Name: Femtex 100% Cotton Gentle Touch Tampons

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

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

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

The material used in Femtex 100% Cotton Gentle Touch tampons are similar to those used in other legally marketed tampons.

Intended Use: Femtex 100% Cotton 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 100% Cotton 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
- cytotoxicity 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/K970232](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB/K970232)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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