510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K132819Substantially Equivalent

Playtex (Scented and Unscented) Sport Fresh Balance Tampons

Playtex Manufacturing Inc., Allendale NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132819 is the FDA 510(k) clearance record for PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS, a class II device, cleared for Playtex Manufacturing, Inc. on under FDA product code HIL (Tampon, Menstrual, Scented, Scented-Deodorized). FDA's definition for product code HIL reads: "A scented or scented-deodorized menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge". FDA records list 3 510(k) clearances for Playtex Manufacturing, Inc., from to . As of , FDA records show no recalls naming K132819.

Clearance record

Decision date
Received
(30 days to decision)
Product code
HIL Tampon, Menstrual, Scented, Scented-Deodorized
Regulation
21 CFR 884.5460
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Playtex Manufacturing, Inc. 75 Commerce Dr., Allendale NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIL

Trailing 12 months

FDA records hold no clearances under product code HIL in the trailing twelve months.

FDA records show no clearances under product code HIL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HIL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260