PLAYTEX MANUFACTURING INC.

FDA Device Registration & Listing · DOVER, DE, US · Registration 2515444

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2515444
FEI Number
2515444
Entity Name
PLAYTEX MANUFACTURING INC.
City/State/Country
DOVER, DE, US
Establishment Address
804 Walker Rd, DOVER, DE 19904, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device
Owner / Operator
Essity Hygiene and Health AB (Owner Number: 9040833)
Owner / Operator Contact Address
Molndal Bro 2, Gothenburg, SE-O SE-405 03, SE
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K122603
PMA Number
N/A

All Registered Proprietary Names

CAREFREE® Original Liners CAREFREE® Acti-fresh Liners STAYFREE® Ultra Thin Pads STAYFREE® Maxi Pads Saba Menstrual Pads, Scented o.b. Original Tampons - applicator and non-applicator versions Playtex Stella STAYFREE® Ultra Thin Pads CAREFREE® Original Liners STAYFREE® Maxi Pads Saba Menstrual Pad Unscented CAREFREE® Breathe™ Ultra Thin Pads CAREFREE® Acti-fresh Liners Playtex® Sport™ Liners Playtex® Gentle Glide (Unscented) Tampons Playtex® Gentle Glide (Unscented) Multipack Tampons Playtex® Gentle Glide Plastic (Scented) Tampons Playtex® Gentle Glide Plastic (Unscented) Tampons Playtex® Gentle Glide Plastic (Scented) Multipack Tampons Playtex® Gentle Glide Plastic (Unscented) Multipack Tampons o.b. Original Tampons - applicator and non-applicator versions Playtex® Non-deodorant and Deodorant Slimfits® Playtex® Nondeodorant and Deodorant Gentle Glide® Multipack Tampons Playtex® Non-deodorant and Deodorant Portables Playtex® Non-deodorant, Deodorant and Odor-absorbing Gentle Glide® TENA® Dry Comfort™ Briefs Carefree Serenity lights by TENA TENA Intimates TENA Stylish TENA Comfort / TENA ProSkin™ Fully Breathable Absorbent Pads TENA Stretch / TENA ProSkin™ Stretch Briefs TENA ProSkin™ Stretch Ultra Briefs 2XL TENA Super / TENA ProSkin™ Super Briefs TENA Fixation / TENA ProSkin™ Comfort Pants TENA Men Super Plus TENA® Stretch Plus Briefs 2XL TENA Sensitive Care TENA ProSkin™ Stretch Super Briefs 3XL TENA ProSkin™ Plus Protective Underwear TENA® Stretch Plus Briefs TENA Ultra / TENA ProSkin™ Ultra Briefs TENA ProSkin™ Overnight Super Protective Underwear TENA Dry Comfort® Protective Underwear TENA ProSkin™ Extra Protective Underwear TENA Intimates Overnight TENA Men Shield TENA ProSkin™ Underwear for Women TENA ProSkin™ Flex TENA ProSkin® Plus XS Brief TENA ProSkin™ Underwear for Men TENA® Complete Briefs TENA Sensitive Care Overnight TENA® Classic Protective Underwear TENA Proskin™ TENA Men Guard Stayfree TENA Complete +Care Ultra™ Briefs Playtex® Gentle Glide (Scented) Tampons Playtex® Simply Gentle Glide (Unscented) Tampons Playtex® Gentle Glide (Unscented) Tampons Playtex® Simply Gentle Glide (Scented) Tampons Playtex® Clean Comfort Tampons Playtex® Sport Plastic Tampons, Fresh Scent Playtex® Sport Plastic, Unscented Playtex® Deodorant Tampons (Model 34802) Ontex Unscented Digital and Plastic and Cardboard Applicator Tampons

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NRC Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile Obstetrics/Gynecology Class 1 884.5425 2011-03-18
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2026-04-08
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2026-04-08
HHD Pad, Menstrual, Unscented Obstetrics/Gynecology Class 1 884.5435 1997-01-22
HIL Tampon, Menstrual, Scented, Scented-Deodorized Obstetrics/Gynecology Class 2 884.5460 2026-04-08
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2026-04-08
HIL Tampon, Menstrual, Scented, Scented-Deodorized Obstetrics/Gynecology Class 2 884.5460 2026-04-08
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2026-04-08
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2026-04-08
HIL Tampon, Menstrual, Scented, Scented-Deodorized Obstetrics/Gynecology Class 2 884.5460 2026-04-08
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2026-04-08
EYQ Garment, Protective, For Incontinence Gastroenterology, Urology Class 1 876.5920 2003-01-29
HIL Tampon, Menstrual, Scented, Scented-Deodorized Obstetrics/Gynecology Class 2 884.5460 2026-04-08
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2026-04-08
HIL Tampon, Menstrual, Scented, Scented-Deodorized Obstetrics/Gynecology Class 2 884.5460 2026-04-08
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2026-04-08
HIL Tampon, Menstrual, Scented, Scented-Deodorized Obstetrics/Gynecology Class 2 884.5460 2026-04-08
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2026-04-08

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Essity Hygiene and Health AB
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3015114852 Essity Netherlands B.V. Zeist Utrecht, NL
3014559678 ESSITY OPERATION POLAND Sp.Z o. o. Olawa, Poland Slaskie, PL
9710130 Essity Hygiene Health AB FALKENBERG Halland, SE
8030877 Essity Hygiene and Health AB Gothenburg Vastra Gotaland, SE
1039577 Essity HMS North America Inc. BOWLING GREEN, KY, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K923985 Personal Products Co. UNSCENTED MENSTRUAL TAMPON 1993-02-19
K151170 Tosama, D.O.O. Tosama 100% Organic Cotton Menstrual Tampon 2015-07-02
K930149 Kimberly-Clark Corp. KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+ 1994-03-02
K823241 Kimberly-Clark Corp. NEW FREEDOM THIN UNSCENTED MAXI PADS 1982-12-28

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3007697999 KIMBERLY-CLARK PERU S.R.L. - Santa Clara Mill Lima Lima (Region), PE
3008111543 AAB (CHINA) CO., LTD. Nanan City Fujian, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2515444. Last updated year: 2026. Please use registration number 2515444 when referencing this establishment in official correspondence.
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