Playtex, Inc.
Allendale, NJ, US
Playtex, Inc. appears in FDA device records in Allendale, NJ. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Playtex, Inc. between 1981 and 2012. The busiest year on record is 1981, with 8. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 8 |
| 1983 | 1 |
| 1984 | 3 |
| 1988 | 2 |
| 1994 | 2 |
| 1995 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K120245 | PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS | HIL | Substantially Equivalent | |
| K980478 | PLAYTEX TAMPONS #03498 | HEB | Substantially Equivalent | |
| K971174 | PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS | HEB | Substantially Equivalent | |
| K944064 | PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22894 | HEB | Substantially Equivalent | |
| K941044 | PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194 | HIL | Substantially Equivalent | |
| K942418 | PLAYTEX TAMPONS MODEL 13794 | HEB | Substantially Equivalent | |
| K881057 | PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER | HIL | Substantially Equivalent | |
| K874509 | PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABEL | HIL | Substantially Equivalent | |
| K843551 | PLAYTEX BABY POWDER DEODORANT TAMPONS | HIL | Substantially Equivalent | |
| K841155 | DEODORANT SLENDER REG. TAMPONS | HIL | Unknown | |
| K841154 | PLAYTEX SLENDER REGULAR TAMPONS | HIL | Unknown | |
| K830966 | PLAYTEX TAMPONS | HIL | Substantially Equivalent | |
| K812870 | IMPROVED PLAYTEX TAMPON | HEB | Substantially Equivalent | |
| K812534 | IMPROVED PLAYTEX TAMPON | HIL | Substantially Equivalent | |
| K811389 | PLAYTEX COTTON TAMPONS | HIL | Substantially Equivalent | |
| K811388 | PLAYTEX COTTON DIGITAL TAMPON | HEB | Substantially Equivalent | |
| K811387 | PLAYTEX COMBINATION FIBER MODIFIED TAMP | HIL | Substantially Equivalent | |
| K811385 | PLAYTEX DIGITAL TAMPON | HEB | Substantially Equivalent | |
| K811660 | PLAYTEX MODIFIED FIBER TAMPONS | HIL | Substantially Equivalent | |
| K811386 | PLAYTEX PROCESS MACHINERY CHANGE | HIL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain