Playtex, Inc. FDA Record
Playtex, Inc. has 0 FDA recalls, 0 inspections, 20 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Playtex, Inc." is on file.
- Latest 510(k)
- Jun 21, 2012
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 20 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K120245 | PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS | Jun 21, 2012 |
| K980478 | PLAYTEX TAMPONS #03498 | Apr 3, 1998 |
| K971174 | PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS | May 21, 1997 |
| K944064 | PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22894 | Feb 9, 1995 |
| K941044 | PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194 | Jul 27, 1994 |
| K942418 | PLAYTEX TAMPONS MODEL 13794 | Jul 8, 1994 |
| K881057 | PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER | Mar 22, 1988 |
| K874509 | PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABEL | Jan 7, 1988 |
| K843551 | PLAYTEX BABY POWDER DEODORANT TAMPONS | Dec 3, 1984 |
| K841154 | PLAYTEX SLENDER REGULAR TAMPONS | Mar 19, 1984 |
| K841155 | DEODORANT SLENDER REG. TAMPONS | Mar 19, 1984 |
| K830966 | PLAYTEX TAMPONS | Apr 8, 1983 |
| K812870 | IMPROVED PLAYTEX TAMPON | Oct 29, 1981 |
| K812534 | IMPROVED PLAYTEX TAMPON | Sep 21, 1981 |
| K811387 | PLAYTEX COMBINATION FIBER MODIFIED TAMP | Aug 7, 1981 |
| K811388 | PLAYTEX COTTON DIGITAL TAMPON | Aug 7, 1981 |
| K811389 | PLAYTEX COTTON TAMPONS | Aug 7, 1981 |
| K811385 | PLAYTEX DIGITAL TAMPON | Aug 7, 1981 |
| K811660 | PLAYTEX MODIFIED FIBER TAMPONS | Jul 16, 1981 |
| K811386 | PLAYTEX PROCESS MACHINERY CHANGE | Jul 10, 1981 |
Playtex, Inc. and the FDA: common questions
Has Playtex, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Playtex, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Playtex, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Playtex, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
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