PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS

Q: Who is the manufacturer of PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS?

Playtime Products, Inc. submitted the Traditional clearance for PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS (K964269).

Q: What is the FDA product code for PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS?

HIL. It is classified under 21 CFR 884.5460 as a Class 2 device in the Obstetrics/Gynecology panel.

Q: What is the regulatory pathway for PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS?

510(k) clearance (submission type: Traditional).

K964269 · Playtime Products, Inc. · HIL · Nov 29, 1996 · Obstetrics/Gynecology

Device Facts

Record ID	K964269
Device Name	PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS
Applicant	Playtime Products, Inc.
Product Code	HIL · Obstetrics/Gynecology
Decision Date	Nov 29, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.5460
Device Class	Class 2

Device Story

Playtex Tampons #29696; feminine hygiene device for menstrual fluid absorption. Safety testing includes TSST-1 toxin analysis, dioxin analysis, and biocompatibility assessments (primary dermal irritation, acute oral toxicity, subacute vaginal irritation, human repeat insult patch test, agar diffusion). Device performance and safety profile compared to commercially sold tampons.

Clinical Evidence

Human Repeat Insult Patch Test conducted; results indicated device is non-irritating and not a sensitizer. Additional non-clinical testing: TSST-1 toxin analysis, dioxin analysis, primary dermal irritation (rabbits), acute oral toxicity (rats), subacute vaginal irritation (rabbits), and agar diffusion study.

Technological Characteristics

Absorbent feminine hygiene tampon. Materials tested for biocompatibility and toxin levels. No specific dimensions or energy sources described.

Indications for Use

Indicated for use as a feminine hygiene product (tampon) for the absorption of menstrual fluid.

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.

Related Devices

K980478 — PLAYTEX TAMPONS #03498 · Playtex, Inc. · Apr 3, 1998
K111684 — PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD · Playtex Manufacturing, Inc. · Feb 3, 2012
K120245 — PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS · Playtex, Inc. · Jun 21, 2012
K050660 — FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS · First Quality Hygienic, Inc. · May 12, 2005
K051446 — FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS · First Quality Hygienic, Inc. · Jul 14, 2005

Submission Summary (Full Text)

{0} NOV 29 1996 K964269 # 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 #29696 and the predicate device - Dioxin Analysis - Primary Dermal Irritation in Rabbits - Non-Irritating - Acute Oral Toxicity in Rats - Non-Toxic - Subacute Vaginal Irritation in Rabbits - Non-Irritating - Human Repeat Insult Patch Test - Non-Irritating and not a Sensitizer - Agar Diffusion Study - No zones of inhibition were detected