PLAYTEX TAMPONS #10296

K961456 · Playtime Products, Inc. · HIL · Jun 18, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K961456
• Device Name: PLAYTEX TAMPONS #10296
• Applicant: Playtime Products, Inc.
• Product Code: HIL · Obstetrics/Gynecology
• Decision Date: Jun 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5460
• Device Class: Class 2

Device Story

RAD-KOTE K261 epoxy coated applicator; used for tampon application. Device consists of applicator, pledget, and string. Safety testing performed on aqueous extract to ensure biocompatibility and non-toxicity for vaginal use.

Clinical Evidence

Bench testing only. Primary Dermal Irritation (rabbits): non-irritant. Oral Toxicity (rats): non-toxic. Subacute Vaginal Irritation (rabbits): non-irritating. Agar Diffusion: no zones of inhibition. Toxin Study: comparable to commercial tampons. Repeat Insult Patch Test (humans): no irritation/sensitization. Dioxin Analysis: non-detectable via HRGG/HRMS Method 8290. Lamination Bond Integrity: no delamination. Cytotoxicity: no cell lysis/toxicity.

Technological Characteristics

RAD-KOTE K261 epoxy coated applicator. Materials tested for biocompatibility and toxicity. Lamination bond integrity verified.

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 18 1996
K961+56

# SUMMARY OF SAFETY AND EFFECTIVENESS

The following tests have been completed on an aqueous extract from the RAD-KOTE K261 epoxy coated applicator covered by this 510(k).

1. Primary Dermal Irritation in Rabbits - Not a primary irritant
2. Oral Toxicity in Rats - Non-toxic
3. Subacute Vaginal Irritation in Rabbits - Non-irritating
4. Agar Diffusion Study - No zones of inhibition were seen (Exhibit 6).
5. Toxin Study - Results were in the range of values of commercially sold tampons (Exhibit 7).
6. Repeat Insult Patch Test in Humans - No irritation or sensitization reported
*7. Dioxin Analysis - Not detectable at limits of detection of HRGG/HRMS Method 8290 (Triangle Labs, North Carolina) (Exhibit 8)
**8. Lamination Bond Integrity Test - No delamination reported (Exhibit 9)
9. Cytotoxicity Test - No evidence of cell lysis or toxicity was reported.

* Tests conducted on applicator, pledget and string.
** Tests conducted on applicator only.