Data / Medical devices / United States / Essity HMS North America Inc.
Essity HMS North America Inc.: FDA-registered device maker in Dover, DE, United States, 14 510(k) clearances
Essity HMS North America Inc. is registered with the FDA (registration 2515444) in Dover, DE, United States. It lists 5 device types. The FDA files 14 510(k) clearances under its listings, the newest dated May 30, 2018. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2515444
- Address
- 804 Walker Rd, Dover, DE, United States, 19904
- Owner or operator
- Essity Hygiene and Health AB (9040833)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 22, 1997
- Registered through
- 2026
- Brand names listed
- CAREFREE® Acti-fresh Liners, CAREFREE® Breathe Ultra Thin Pads, CAREFREE® Original Liners, Carefree, Ontex Unscented Digital and Plastic and Cardboard Applicator Tampons, Playtex Stella, Playtex® (Scented) Sport Fresh Balance Tampon, Playtex® (Unscented) Sport Fresh Balance Tampons and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tampon, Menstrual, Scented, Scented-Deodorized | HIL | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | NRC | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 30, 2018 | K180167 | Playtex Stella Tampons | HEB | Substantially Equivalent | Playtex Manufacturing, Inc. | accessdata.fda.gov |
| October 9, 2013 | K132819 | PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS | HIL | Substantially Equivalent | Playtex Manufacturing, Inc. | accessdata.fda.gov |
| December 19, 2012 | K122603 | ONTEX AND OTHER PROPRIETARY NAMES | HEB | Substantially Equivalent | Ontex Bvba | accessdata.fda.gov |
| June 21, 2012 | K120245 | PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS | HIL | Substantially Equivalent | Playtex, Inc. | accessdata.fda.gov |
| February 3, 2012 | K111684 | PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD | HIL | Substantially Equivalent | Playtex Manufacturing, Inc. | accessdata.fda.gov |
| January 17, 2008 | K073662 | PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS | HIL | Substantially Equivalent | Playtex Products, Inc. | accessdata.fda.gov |
| December 12, 2007 | K072376 | PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS | HIL | Substantially Equivalent | Playtex Products, Inc. | accessdata.fda.gov |
| April 13, 2007 | K070745 | MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS | HIL | Substantially Equivalent | Playtex Products, Inc. | accessdata.fda.gov |
| May 9, 2006 | K060981 | PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS | HIL | Substantially Equivalent | Playtex Products, Inc. | accessdata.fda.gov |
| December 6, 2002 | K023789 | O.B. TAMPONS | HEB | Substantially Equivalent | Mcneil-Ppc, Inc. | accessdata.fda.gov |
| September 16, 2002 | K022882 | MODIFICATION TO PLAYTEX TAMPONS #24002 | HIL | Substantially Equivalent | Playtex Products, Inc. | accessdata.fda.gov |
| March 13, 2002 | K020200 | PLAYTEX DEODORANT TAMPONS, MODEL 34802 | HIL | Substantially Equivalent | Playtex Products, Inc. | accessdata.fda.gov |
| August 31, 1999 | K990536 | O.B. TAMPON | HEB | Substantially Equivalent | Personal Products Co. | accessdata.fda.gov |
| February 10, 1998 | K974629 | O.B. APPLICATOR AND NON-APPLICATOR TAMPONS | HEB | Substantially Equivalent | Personal Products Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Tampon, Menstrual, Unscented
- All makers of Tampon, Menstrual, Scented, Scented-Deodorized
- All makers of Pad, Menstrual, Unscented
- All makers of Garment, Protective, For Incontinence
- All makers of Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile
Updated May 30, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.