510(k) Report

510(k) · Cleared

Cleared

Powder Free Nitrile Patient Examination Glove, Blue and White Colored, Non-Sterile

K123469510(k) TraditionalCleared Feb 19, 201398-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

Wear Safe (Malaysia) Sdn Bhd - Facility II · LZA Polymer Patient Examination Glove

Cleared on Feb 19, 2013 as substantially equivalent to K093500 (Wear Safe (Malaysia) Sdn. Bhd., 2010) and 1 other predicate after a 98-day review. Its family tree reaches back 2 generations to 2007. 10 later devices descend from it.

Decided
Feb 19, 2013
Review
98 days
Class
Class I
Product code
LZA
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K062764 (2007). 3 ancestors in all. 10 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2015: 1 descendant cleared2017: 2 descendants cleared2021: 3 descendants cleared2022: 1 descendant cleared2023: 2 descendants cleared2026: 1 descendant clearedK062764 · Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue Colored · Kossan Latex Industries (M)Sdn Bhd · 2007K111772 · Powder Free Nitrile Patient Examination Glove, Blue Colored and White (Non-Colored). Non-Sterile · Kossan Latex Industries (M)Sdn Bhd · 201120052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants K111772 · Powder Free Nitrile Patient Examination Glove, Blue Colored and White (Non-Colored). Non-Sterile · Kossan Latex Industries (M)Sdn Bhd · 2011K062764 · Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue Colored · Kossan Latex Industries (M)Sdn Bhd · 20070
  1. Root · 2 generations backK062764 Powder-Free Nitrile Patient Examination Glove, White (Non-Colored)…Kossan Latex Industries (M)Sdn Bhd · 2007
  2. 1 generation backK111772 Powder Free Nitrile Patient Examination Glove, Blue Colored and…Kossan Latex Industries (M)Sdn Bhd · 2011
  3. This deviceK123469 Powder Free Nitrile Patient Examination Glove, Blue and White…Wear Safe (Malaysia) Sdn Bhd - Facility II · 2013
  4. Descendant · cites it directly · 8 of its ownK142862 POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).Careplus (M) Sdn Bhd · 2015
  5. Descendant · 2 generations on · 5 of its ownK172015 Powder Free Nitrile Examination Gloves, Blue (Colored)Careglove Global Sdn. Bhd. · 2017
  6. Descendant · 3 generations on · 2 of its ownK220442 Synguard Nitrile Exam GloveTianjin Aoshang Outdoor Equipment Co., Ltd. · 2022
  7. Descendant · 2 generations on · 1 of its ownK201857 Powder Free Nitrile Examination Glove Black and Dual Color White-BlueCareplus (M) Sdn Bhd · 2021
  8. Descendant · 4 generations on · 0 of its ownK253160 Syntex Exam GlovesBasic Medical Technology, Inc. · 2026

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2015: 12017: 22021: 32022: 12023: 22026: 1
2015high 3 (2021) · low 0 (2016)2026

Most influential descendants

Showing 5 of 10 · See all
  • K142862POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).Careplus (M) Sdn Bhd · 2015 · cites it directly8descendants
  • K172015Powder Free Nitrile Examination Gloves, Blue (Colored)Careglove Global Sdn. Bhd. · 2017 · 2 generations on5descendants
  • K220442Synguard Nitrile Exam GloveTianjin Aoshang Outdoor Equipment Co., Ltd. · 2022 · 3 generations on2descendants
  • K201857Powder Free Nitrile Examination Glove Black and Dual Color White-BlueCareplus (M) Sdn Bhd · 2021 · 2 generations on1descendant
  • K253160Syntex Exam GlovesBasic Medical Technology, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K062764Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue…Kossan Latex Industries (M)Sdn Bhd2007—
−1K111772Powder Free Nitrile Patient Examination Glove, Blue Colored and White…Kossan Latex Industries (M)Sdn Bhd2011—
0 (this device)K123469Powder Free Nitrile Patient Examination Glove, Blue and White Colored…Wear Safe (Malaysia) Sdn Bhd - Facility II2013—
+1K142862POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).Careplus (M) Sdn Bhd2015—
+2K172015Powder Free Nitrile Examination Gloves, Blue (Colored)Careglove Global Sdn. Bhd.2017—
+3K220442Synguard Nitrile Exam GloveTianjin Aoshang Outdoor Equipment Co., Ltd.2022—
+2K201857Powder Free Nitrile Examination Glove Black and Dual Color White-BlueCareplus (M) Sdn Bhd2021—
+4K253160Syntex Exam GlovesBasic Medical Technology, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201720
202130
202210
202320
202610
FIG. 1 — Lineage of K123469, 2007–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (2)

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
*K093500Powder Free Nitrile Examination Gloves, White (Non-Colored) or Blue (Colored), Non-Sterile
Summary page 1
…ZA, meets all of the requirements of ASTM D 6319-10 Standard Specification for Nitrite Examination Gloves for Medical Application. Predicate Device 1: K093500, Powder Free Nitrite Examination Glove, White (Non-Colored) and Blue (Colored), Non-Sterile (Chemotherapy Drug Protection…
Wear Safe (Malaysia) Sdn. Bhd.2010—
*K111772Powder Free Nitrile Patient Examination Glove, Blue Colored and White (Non-Colored).…
Summary page 1
…Free Nitrite Examination Glove, White (Non-Colored) and Blue (Colored), Non-Sterile (Chemotherapy Drug Protection Labeling Claim). Predicate Device 2: K111772, Powder Free Nitrite Patient Examination Glove, Blue Colored and White (Non-Colored), Non-Sterile.…
Kossan Latex Industries (M)Sdn Bhd2011—

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K142862POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).Careplus (M) Sdn Bhd20158
K171737Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination GlovesAnsell Healthcare Products, LLC20170

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?

  • The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K142862 (Careplus (M) Sdn Bhd, 2015) has gone furthest, with 8 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. 2013, this device’s year, is highlighted.

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 patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

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

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/K123469 · printed Nov 5, 2026

Cite this page

510(k) Report. “K123469: Powder Free Nitrile Patient Examination Glove, Blue and White Colored, Non-Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123469

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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