← Product Code [HEB](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB) · K963032

# FREE CHOICE (K963032)

_First Quality Hygienic, Inc. · HEB · Oct 11, 1996 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB/K963032

## 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:** Oct 11, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.5470
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Indications for Use

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

## Device Story

Menstrual tampon; non-applicator design; inserted into vagina to absorb menstrual fluid. Available in regular, super, and super plus absorbencies. Used by individuals during menstruation. Device functions via physical absorption of fluid.

## Clinical Evidence

Bench testing only. Biocompatibility testing performed including irritation, sensitization, cytotoxicity, and vaginal irritation testing. Absorbency verified via standard Syngyna testing. No clinical data presented.

## Technological Characteristics

Materials: rayon, polyethylene, polypropylene overwrap, cotton cord. Form factor: digital (non-applicator) tampon. Absorbency: regular, super, super plus. Testing: Syngyna standard.

## 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 ([K963032](/device/K963032.md))

## 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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FIRST QUALITY HYGIENIC, INC.
CLINTON COUNTY INDUSTRIAL PARK
P.O. BOX 330/NORTH ROAD/McELHATTAN, PA 17748
TEL 717-269-6900
FAX 717-269-7481

OCT 11 1996

510K SUMMARY

K963032

**Device Name:** Femtex Digital Tampons

**Legally marketed device:** Femtex Digital Tampons are substantially equivalent to legally marketed Femtex tampons with applicators.

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

Femtex Digital Tampons are made from rayon, polyethylene and polypropylene overwrap and cotton cord. There is no applicator

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

**Intended Use:** Femtex Digital 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 Digital Tampons was carried out. The results of these tests demonstrate that Femtex Digital Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons. Standard Syngyna testing confirmed the absorbency of Femtex Digital 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 Digital tampons.

- irritation testing
- sensitization testing
- cytotoxicity 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/K963032](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB/K963032)

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