510(k) · Cleared
ClearedPlaytex Tampons #14897/Playtex Gentle Glide,Silk Glide, Slimfits,Soft Comfort and Portables Tampons
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Playtex Products, Inc. · HIB Speculum, Vaginal, Nonmetal
Cleared on Sep 26, 1997 after a 120-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 26, 1997
- Review
- 120 days
- Class
- Class II
- Product code
- HIB
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HIB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HIB device
- #1 K252208 JFord Speculum Sleeve™score 11.9 · 4 generations · no Class I recall
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Playtex Gentle Glide® Tampons Named without a submission number | |
| * | — | Playtex Silk Glide® Tampons Named without a submission number | |
| * | — | Playtex Slimfits™ Tampons Named without a submission number | |
| * | — | Playtex Soft Comfort™ Tampons Named without a submission number | |
| * | — | Playtex Portables® Tampons Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All HIB devicesHIB Speculum, Vaginal, Nonmetal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIB
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · HIB
Too few HIB 510(k)s in any year since 2007 to give a median.
Recalls per year · HIB
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIB
3in 2025
MAUDE reports naming product code HIB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 10 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 15 |
| 2013 | 1 | — | 0 | 9 |
| 2014 | 2 | — | 0 | 8 |
| 2015 | 0 | — | 1 | 5 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Scented, Scented Deodorant and Unscented menstrual tampons for absorption of menstrual fluid: Part 21 C. F. R., Section 884.5460 and Section 884.5470 respectively.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971979 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971979: Playtex Tampons #14897/Playtex Gentle Glide,Silk Glide, Slimfits,Soft Comfort and Portables Tampons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971979
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026