PLAYTEX SLIMFIT TAMPONS

K961870 · Playtex Products, Inc. · HIL · Jun 19, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K961870
• Device Name: PLAYTEX SLIMFIT TAMPONS
• Applicant: Playtex Products, Inc.
• Product Code: HIL · Obstetrics/Gynecology
• Decision Date: Jun 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5460
• Device Class: Class 2

Device Story

Playtex Tampons #12496 (Slimfit Tampon) designed for menstrual fluid absorption. Testing confirms TSST-1 toxin levels comparable to commercially available tampons; Syngyna absorbency ranges: Regular (6-9 gms), Super (9-12 gms). Dioxin analysis via HRGG/HRMS Method 8290 shows non-detectable levels.

Clinical Evidence

Bench testing only. TSST-1 toxin levels compared to commercial tampons; Syngyna absorbency testing performed; Dioxin analysis conducted via HRGG/HRMS Method 8290.

Technological Characteristics

Absorbent tampon device. Testing standards: Syngyna absorbency test, HRGG/HRMS Method 8290 for dioxin analysis.

Regulatory Classification

Identification

A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.

Submission Summary (Full Text)

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JUN 19 1996
K96 1870

# 9. SUMMARY OF SAFETY AND EFFECTIVENESS

TSST-1, Toxin testing was conducted; results are in the range of values of commercially sold tampons and there are no significant differences between Playtex Tampons #12496 (Slimfit Tampon) and the predicate device (Exhibit 4).

Syngyna test results are reported in Section 6 - Regular and Super absorbency ranges are within 6-9 gms and 9-12 gms respectively.

Dioxin Analysis - Not detectable at limits of detection of HRGG/HRMS Method 8290 (Triangle Labs, North Carolina). Summary provided in Exhibit 5.