# Playtex Products, Inc.

- Location (FDA's records): Allendale, NJ
- FDA decisions: 17 (1995–2008): 17 510(k) clearances
- Product codes: HIL (11), HEB (3), HGX (2), HIB (1)
- Predicates its devices cite: 22 (9 its own); citations of its devices by later devices: 16 (9 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Playtex, Inc.: 3 (https://510kreport.com/company/playtex)
- Playtime Products, Inc.: 2 (https://510kreport.com/company/playtime-products)
- Hollister, Inc.: 2 (https://510kreport.com/company/hollister)
- Medela AG: 2 (https://510kreport.com/company/medela)
- Ameda Medizintechnik AG: 2 (https://510kreport.com/company/ameda-medizintechnik)
- Playtex Family Products, Inc.: 2 (https://510kreport.com/company/playtex-family-products)

## Firms that cite its devices most
- Playtex, Inc.: 3 (https://510kreport.com/company/playtex)
- Playtex Manufacturing, Inc.: 2 (https://510kreport.com/company/playtex-manufacturing)
- Gerber Products Co.: 1 (https://510kreport.com/company/gerber-products)
- Uzinmedicare Co.: 1 (https://510kreport.com/company/uzinmedicare)

## Its most-cited devices
- K070745: Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack Tampons (2007), cited by 4
- K020201: Playtex Deodorant Tampons, Model 34902 (2002), cited by 2
- K022594: Playtex Breast Pump (2002), cited by 2
- K961870: Playtex Slimfit Tampons (1996), cited by 2
- K061013: Playtex Embrace Petite Breast Pump (2006), cited by 1
- K060981: Playtex Sport Plastic, Playtex Sport Plastic Multipack Tampons (2006), cited by 1

## Recent decisions
- K073662: Playtex Gentile Glide, Playtex Gentile Glide Multipack Tampons (Jan 17, 2008)
- K072376: Playtex Gentle Glide, Playtex Gentle Glide Multipack Tampons (Dec 12, 2007)
- K070745: Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack Tampons (Apr 13, 2007)
- K061013: Playtex Embrace Petite Breast Pump (Aug 15, 2006)
- K060981: Playtex Sport Plastic, Playtex Sport Plastic Multipack Tampons (May 9, 2006)
- K032636: Playtex Unscented Cardboard Applicator Tampon #13203 (Colored) and # 13203 PV (Non-Colored) (Nov 14, 2003)
- K022594: Playtex Breast Pump (Nov 1, 2002)
- K022882: Modification to Playtex Tampons #24002 (Sep 16, 2002)

Source page: https://510kreport.com/company/playtex-products