510(k) Report

510(k) · Cleared

Cleared

Safeskin Sterile Purple Nitrile Examination Gloves

K992062510(k) TraditionalCleared Aug 25, 199968-day reviewClass I21 CFR 880.6250

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

Safeskin Corp. · LZA Polymer Patient Examination Glove

Cleared on Aug 25, 1999 after a 68-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.

Decided
Aug 25, 1999
Review
68 days
Class
Class I
Product code
LZA
Recalls
None
Predicates
0

10 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2008: 1 descendant cleared2012: 1 descendant cleared2025: 2 descendants cleared2020: 1 descendant cleared2016: 1 descendant cleared2017: 2 descendants cleared2018: 1 descendant cleared1995200020052010201520202025
  1. This deviceK992062 Safeskin Sterile Purple Nitrile Examination GlovesSafeskin Corp. · 1999
  2. Descendant · cites it directly · 9 of its ownK081027 Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile)Kimberly-Clark Corp. · 2008 · Recalled
  3. Descendant · cites it directly · 8 of its ownK102032 Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove…Kimberly-Clark Corp. · 2010
  4. Descendant · 2 generations on · 5 of its ownK113423 Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free…Kimberly-Clark Corp. · 2012
  5. Descendant · 3 generations on · 2 of its ownK160709 HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health · 2016
  6. Descendant · 4 generations on · 0 of its ownK243604 Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis…O&M Halyard, Inc. · 2025

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2008: 12010: 12012: 12016: 12017: 22018: 12020: 12025: 2
2008high 2 (2017) · low 0 (2009)2026

Most influential descendants

Showing 5 of 10 · See all
  • K081027Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile)Kimberly-Clark Corp. · 2008 · cites it directly9descendants
  • K102032Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove)…Kimberly-Clark Corp. · 2010 · cites it directly8descendants
  • K113423Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam GloveKimberly-Clark Corp. · 2012 · 2 generations on5descendants
  • K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health · 2016 · 3 generations on2descendants
  • K243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested…O&M Halyard, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K992062Safeskin Sterile Purple Nitrile Examination GlovesSafeskin Corp.1999—
+1K081027Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile)Kimberly-Clark Corp.20081
+1K102032Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove…Kimberly-Clark Corp.2010—
+2K113423Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam GloveKimberly-Clark Corp.2012—
+3K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health2016—
+4K243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis…O&M Halyard, Inc.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201210
201610
201720
201810
202010
202520
FIG. 1 — Lineage of K992062, 1999–2025Source: 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 LZA? 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 LZA device

  1. #1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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
*—Safeskin Blue Nitrile Examination Glove
Named without a submission number
—

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K081027Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile)Kimberly-Clark Corp.20089
K102032Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove)…Kimberly-Clark Corp.20108

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?

  • Of its descendants, K081027 (Kimberly-Clark Corp., 2008) has gone furthest, with 9 descendants of its own.

How does its category compare?

All LZA devices

LZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZA

24in 2025

2007: 212008: 182009: 282010: 312011: 262012: 332013: 202014: 272015: 202016: 302017: 442018: 222019: 252020: 302021: 1392022: 1462023: 622024: 302025: 242026 (partial year): 15
2007high 146 (2022) · low 18 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZA

110in 2025

2007: 95 days median2008: 97 days median2009: 112 days median2010: 97 days median2011: 122 days median2012: 110 days median2013: 130 days median2014: 197 days median2015: 112 days median2016: 171 days median2017: 124 days median2018: 178 days median2019: 212 days median2020: 101 days median2021: 111 days median2022: 111 days median2023: 92 days median2024: 89 days median2025: 110 days median2026 (partial year): 103 days median
2007high 212 (2019) · low 89 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZA

3so far in 2026, the most since 2007

2015: 12016: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZA

73in 2025

2007: 72008: 22009: 122010: 122011: 92012: 112013: 102014: 82015: 122016: 252017: 42018: 32019: 212020: 42021: 202022: 192023: 242024: 762025: 73
2007high 76 (2024) · low 2 (2008)2025

MAUDE reports naming product code LZA, 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
2007219507
2008189702
200928112012
20103197012
20112612209
201233110011
201320130010
20142719708
201520112112
201630171125
20174412404
20182217803
201925212021
20203010104
2021139111020
2022146111019
20236292024
20243089076
202524110073
2026151033—

What is it indicated for?

A medical glove intended to be worn on the hands of healthcare and similar personnel to

prevent contamination between such personnel and the patient.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Safeskin Corp.

24 FDA decisions under this applicant name. See the company

  • K993117Safeskin Pfe-Xtra Powder-Free Latex Examination Gloves, Protein Content 50 MCG or Less, for Use with…Safeskin Corp. · 2000
  • K994081Safeskin Tactylon PF Powder-Free Surgeon's GlovesSafeskin Corp. · 2000
  • K992830Safeskin Polymer-Coated Nitrile Examination Gloves, Powder-Free Shieldmaster Nitrile GloveSafeskin Corp. · 1999
  • K992210Shieldmaster Powdered Purple Nitrile Examination GlovesSafeskin Corp. · 1999
  • K992162Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling ClaimSafeskin Corp. · 1999

Recent decisions in LZA

The LZA category page

  • K262208Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for…Yty Industry (Manjung) Sdn Bhd · 2026
  • K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and…Maxter Healthcare, Inc. · 2026
  • K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination…Top Glove Sdn. Bhd. · 2026
  • K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl…Gmp Medicare Sdn. Bhd. · 2026
  • K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealth · 2026

https://510kreport.com/device/K992062 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992062: Safeskin Sterile Purple Nitrile Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992062

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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