510(k) Report

510(k) · Cleared

Cleared

Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack Tampons

K070745510(k) SpecialCleared Apr 13, 200725-day reviewClass II21 CFR 884.5460

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Playtex Products, Inc. · HIL Tampon, Menstrual, Scented, Scented-Deodorized

Cleared on Apr 13, 2007 as substantially equivalent to K830966 (Playtex, Inc., 1983) and 2 other predicates after a 25-day review. Its family tree reaches back 1 generation to 1983. 6 later devices descend from it.

Decided
Apr 13, 2007
Review
25 days
Class
Class II
Product code
HIL
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K830966 (1983). 3 ancestors in all. 6 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1991: 1 other ancestor2012: 2 descendants cleared2008: 1 descendant cleared2007: 1 descendant cleared2013: 1 descendant cleared2018: 1 descendant clearedK830966 · Playtex Tampons · Playtex, Inc. · 198319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K830966 · Playtex Tampons · Playtex, Inc. · 19830
  1. Root · 1 generation backK830966 Playtex TamponsPlaytex, Inc. · 1983
  2. This deviceK070745 Modification to: Playtex Gentle Glide Plastic, Playtex Gentle…Playtex Products, Inc. · 2007
  3. Descendant · cites it directly · 2 of its ownK111684 Playtex Sport (Unscented) ,(Scented) with OdorshieldPlaytex Manufacturing, Inc. · 2012
  4. Descendant · 2 generations on · 1 of its ownK132819 Playtex (Scented and Unscented) Sport Fresh Balance TamponsPlaytex Manufacturing, Inc. · 2013
  5. Descendant · cites it directly · 1 of its ownK073662 Playtex Gentile Glide, Playtex Gentile Glide Multipack TamponsPlaytex Products, Inc. · 2008
  6. Descendant · cites it directly · 1 of its ownK072376 Playtex Gentle Glide, Playtex Gentle Glide Multipack TamponsPlaytex Products, Inc. · 2007
  7. Descendant · 3 generations on · 0 of its ownK180167 Playtex Stella TamponsPlaytex Manufacturing, Inc. · 2018

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12012: 22013: 12018: 1
2007high 2 (2012) · low 0 (2009)2026

Most influential descendants

Showing 5 of 6 · See all
  • K111684Playtex Sport (Unscented) ,(Scented) with OdorshieldPlaytex Manufacturing, Inc. · 2012 · cites it directly2descendants
  • K132819Playtex (Scented and Unscented) Sport Fresh Balance TamponsPlaytex Manufacturing, Inc. · 2013 · 2 generations on1descendant
  • K073662Playtex Gentile Glide, Playtex Gentile Glide Multipack TamponsPlaytex Products, Inc. · 2008 · cites it directly1descendant
  • K072376Playtex Gentle Glide, Playtex Gentle Glide Multipack TamponsPlaytex Products, Inc. · 2007 · cites it directly1descendant
  • K180167Playtex Stella TamponsPlaytex Manufacturing, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K830966Playtex TamponsPlaytex, Inc.1983—
0 (this device)K070745Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic…Playtex Products, Inc.2007—
+1K111684Playtex Sport (Unscented) ,(Scented) with OdorshieldPlaytex Manufacturing, Inc.2012—
+2K132819Playtex (Scented and Unscented) Sport Fresh Balance TamponsPlaytex Manufacturing, Inc.2013—
+1K073662Playtex Gentile Glide, Playtex Gentile Glide Multipack TamponsPlaytex Products, Inc.2008—
+1K072376Playtex Gentle Glide, Playtex Gentle Glide Multipack TamponsPlaytex Products, Inc.2007—
+3K180167Playtex Stella TamponsPlaytex Manufacturing, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
201220
201310
201810
FIG. 1 — Lineage of K070745, 1983–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 HIL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K830966Playtex Tampons
Summary page 1
…ified) Devices: Playtex Non-deodorant & Deodorant Gentle Glide Playtex Non-deodorant & Deodorant Gentle Glide Multipack Tampons K830966, K020201, K912002 Device Description: Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrua…
Playtex, Inc.1983—
*K020201Playtex Deodorant Tampons, Model 34902
Summary page 1
…vices: Playtex Non-deodorant & Deodorant Gentle Glide Playtex Non-deodorant & Deodorant Gentle Glide Multipack Tampons K830966, K020201, K912002 Device Description: Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.…
Playtex Products, Inc.2002—
*K912002Playtex Non-Deodorant/Deodorant Tampons
Summary page 1
…Playtex Non-deodorant & Deodorant Gentle Glide Playtex Non-deodorant & Deodorant Gentle Glide Multipack Tampons K830966, K020201, K912002 Device Description: Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid. I-WA/…
Playtex Family Products, Inc.1991—

Also cleared against K830966: 2 other devices →

What descends from it? (6)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111684Playtex Sport (Unscented) ,(Scented) with OdorshieldPlaytex Manufacturing, Inc.20122
K073662Playtex Gentile Glide, Playtex Gentile Glide Multipack TamponsPlaytex Products, Inc.20081
K072376Playtex Gentle Glide, Playtex Gentle Glide Multipack TamponsPlaytex Products, Inc.20071
K120245Playtex Gentle Glide Scented Tampons and Playtex Gentle Glide Unscented TamponsPlaytex, Inc.20120

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.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K111684 (Playtex Manufacturing, Inc., 2012) has gone furthest, with 2 descendants of its own.
  • 2 other devices also cite its predicate K830966.

How does its category compare?

All HIL devices

HIL Tampon, Menstrual, Scented, Scented-Deodorized: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · HIL

1in 2014

2007: 22008: 22012: 22013: 12014: 1
2007high 2 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HIL

Too few HIL 510(k)s in any year since 2007 to give a median.

Recalls per year · HIL

No recall names HIL since 2007.

Adverse event reports per year · HIL

1in 2025

2007: 82008: 82009: 132010: 112011: 42012: 22013: 92014: 32015: 32016: 42017: 22018: 12019: 12020: 122021: 72022: 22023: 12024: 12025: 1
2007high 13 (2009) · low 1 (2018)2025

MAUDE reports naming product code HIL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—08
20082—08
20090—013
20100—011
20110—04
20122—02
20131—09
20141—03
20150—03
20160—04
20170—02
20180—01
20190—01
20200—012
20210—07
20220—02
20230—01
20240—01
20250—01
20260—0—

What is it indicated for?

Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.

Indications for use as stated in the FDA summary.

Also cleared against K830966

2 other devices cite the same predicate.

  • K060981Playtex Sport Plastic, Playtex Sport Plastic Multipack TamponsPlaytex Products, Inc. · 2006
  • K022882Modification to Playtex Tampons #24002Playtex Products, Inc. · 2002

More from Playtex Products, Inc.

17 FDA decisions under this applicant name. See the company

  • K073662Playtex Gentile Glide, Playtex Gentile Glide Multipack TamponsPlaytex Products, Inc. · 2008
  • K072376Playtex Gentle Glide, Playtex Gentle Glide Multipack TamponsPlaytex Products, Inc. · 2007
  • K061013Playtex Embrace Petite Breast PumpPlaytex Products, Inc. · 20061 recall
  • K060981Playtex Sport Plastic, Playtex Sport Plastic Multipack TamponsPlaytex Products, Inc. · 2006
  • K032636Playtex Unscented Cardboard Applicator Tampon #13203 (Colored) and # 13203 PV (Non-Colored)Playtex Products, Inc. · 2003

Recent decisions in HIL

The HIL category page

  • K132208Ontex and Others Proprietary NamesOntex Bvba · 2014
  • K132819Playtex (Scented and Unscented) Sport Fresh Balance TamponsPlaytex Manufacturing, Inc. · 2013
  • K120245Playtex Gentle Glide Scented Tampons and Playtex Gentle Glide Unscented TamponsPlaytex, Inc. · 2012
  • K111684Playtex Sport (Unscented) ,(Scented) with OdorshieldPlaytex Manufacturing, Inc. · 2012
  • K081555Tampax Pearl Plastic Applicator Tampons, Scented and UnscentedProcter & Gamble Co. · 20081 recall

https://510kreport.com/device/K070745 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070745: Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack Tampons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070745

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026