TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS

K960341 · Tambrands, Inc. · HEB · Apr 17, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K960341
• Device Name: TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS
• Applicant: Tambrands, Inc.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Apr 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

Tampax Tampons with Additive are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

Device Story

Menstrual tampon; absorbs menstrual fluid; inserted into vagina. Composed of cotton/rayon fibers, overwrap, cotton cord, and additive. Provided in four absorbencies: junior, regular, super, super plus. Includes flushable, biodegradable applicator. Used by patients for menstrual hygiene. Additive safety evaluated via biocompatibility and clinical comparison to control tampons. Output is physical absorption of fluid; clinical benefit is menstrual management.

Clinical Evidence

Clinical study compared Tampax Tampons with Additive to control tampon during normal menstrual use. Evaluated product-related irritation, comfort, and adverse events. Results showed no difference in irritation or comfort between subject and control; no significant or unexpected adverse events observed.

Technological Characteristics

Materials: cotton and/or rayon fibers, overwrap, cotton cord, additive. Form factor: tampon with flushable/biodegradable applicator. Absorbencies: junior, regular, super, super plus. Non-clinical testing: irritation, sensitization, cytotoxicity, genotoxicity, in vitro vaginal microflora, microbiological testing.

Indications for Use

Indicated for use by menstruating individuals for the absorption of menstrual fluid.

Regulatory Classification

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

• Tampax OEF tampons

Submission Summary (Full Text)

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Appendix 8
APR 17 1996
K 9603 41

# 510(k) Summary

**Device Name:** Tampax Tampons with Additive

**Legally marketed device:** Tampax Tampons with Additive are substantially equivalent to legally marketed Tampax OEF tampons.

**Device description:** Tampax Tampons with Additive are menstrual tampons used to absorb menstrual fluid. Tampax Tampons with Additive will be provided in 4 absorbencies, junior, regular, super and super plus

Tampax Tampons with Additive are made of cotton and/or rayon fibers and overwrap, cotton cord, and an additive. The applicator used in Tampax tampons with Additive is flushable and biodegradable.

Except for the additive, the materials used in Tampax Tampons with Additive are identical to those used in other legally marketed Tampax tampons. This additive has been adequately characterized and evaluated using scientifically valid safety tests.

**Intended Use:** Tampax Tampons with Additive are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

## Assessment of performance data

**Non-clinical testing:** Biocompatibility and microbiological testing of the additive and Tampax Tampons with Additive was conducted. The results of these tests demonstrate that Tampax Tampons with Additive are equivalent in terms of safety and effectiveness to legally marketed tampons. In addition to the review of existing toxicological data, the following tests were conducted related to the safety of Tampax Tampons with Additive:

- Irritation and sensitization testing
- Cytotoxicity testing
- Genotoxicity testing
- *In vitro* vaginal microflora testing
- Additional microbiological testing

**Clinical Testing:** A clinical study was done to evaluate the safety of Tampax Tampons with Additive and to compare its safety to its predicates. The study compared Tampax Tampons with Additive to a control tampon during normal menstrual use. Safety was evaluated by comparing the prevalence of product related irritation and other parameters after normal menstrual use.

The study results showed no difference in product related irritation, comfort, or other parameters between Tampax Tampons with Additive and the control product. No significant or unexpected adverse events were observed during the study.

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Conclusions: Results of the non-clinical and clinical tests showed that the additive does not alter the safety or effectiveness of the device and that Tampax Tampons with Additive are as safe and as effective, and perform as well as predicate, legally marketed tampons. Further, the results demonstrated that Tampax Tampons with Additive are substantially equivalent to other legally marketed tampons.

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