# K111684: Playtex Sport (Unscented) ,(Scented) with Odorshield

- Pathway: 510(k) (Traditional)
- Applicant: Playtex Manufacturing, Inc.
- Decided: Feb 3, 2012 after 233 days
- Product code: HIL ( Tampon, Menstrual, Scented, Scented-Deodorized)
- Device class: 2
- Regulation: 21 CFR 884.5460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K830966 (1983). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060981: Playtex Sport Plastic, Playtex Sport Plastic Multipack Tampons, Playtex Products, Inc. (2006) Summary page 2.
- K070745: Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack Tampons, Playtex Products, Inc. (2007) Summary page 1.

## Most influential descendants
- K132819: Playtex (Scented and Unscented) Sport Fresh Balance Tampons (2013), 1 descendant of its own
- K180167: Playtex Stella Tampons (2018), 0 descendants of its own

## Indications for use
Playtex Unscented deodorized menstrmal tampon are intended to be inserted into the vagina and used to absorb menstrual fluid. Absorbency Ranges: Absorbs menstrual flow 6-9 grams (Regular) Absorbs menstrual flow 9-12 grams (Super) Absorbs menstrual flow 12-15 grams (Super Plus) Playtex Scented or scented deodorized menstrual tampon are intended to be inserted into the vagina and used to absorb menstrual fluid. Absorbency Ranges: Absorbs menstrual flow 6-9 grams (Regular) Absorbs menstrual flow 9-12 grams (Super)

Source page: https://510kreport.com/device/K111684
Methodology: https://510kreport.com/methodology