510(k) Report

510(k) · Cleared

Cleared

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

K111772510(k) TraditionalCleared Oct 20, 2011119-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

Kossan Latex Industries (M)Sdn Bhd · LZA Polymer Patient Examination Glove

Cleared on Oct 20, 2011 as substantially equivalent to K062764 (Kossan Latex Industries (M)Sdn Bhd, 2007) after a 119-day review. Its family tree reaches back 1 generation to 2007. 11 later devices descend from it.

Decided
Oct 20, 2011
Review
119 days
Class
Class I
Product code
LZA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K062764 (2007). 11 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2015: 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 · 200720052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 4 descendants5 generations forward: 2 descendants K062764 · Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue Colored · Kossan Latex Industries (M)Sdn Bhd · 20070+5
  1. Root · 1 generation backK062764 Powder-Free Nitrile Patient Examination Glove, White (Non-Colored)…Kossan Latex Industries (M)Sdn Bhd · 2007
  2. This deviceK111772 Powder Free Nitrile Patient Examination Glove, Blue Colored and…Kossan Latex Industries (M)Sdn Bhd · 2011
  3. Descendant · cites it directly · 10 of its ownK123469 Powder Free Nitrile Patient Examination Glove, Blue and White…Wear Safe (Malaysia) Sdn Bhd - Facility II · 2013
  4. Descendant · 2 generations on · 8 of its ownK142862 POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).Careplus (M) Sdn Bhd · 2015
  5. Descendant · 3 generations on · 5 of its ownK172015 Powder Free Nitrile Examination Gloves, Blue (Colored)Careglove Global Sdn. Bhd. · 2017
  6. Descendant · 4 generations on · 2 of its ownK220442 Synguard Nitrile Exam GloveTianjin Aoshang Outdoor Equipment Co., Ltd. · 2022
  7. Descendant · 3 generations on · 1 of its ownK201857 Powder Free Nitrile Examination Glove Black and Dual Color White-BlueCareplus (M) Sdn Bhd · 2021

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2013: 12015: 12017: 22021: 32022: 12023: 22026: 1
2013high 3 (2021) · low 0 (2014)2026

Most influential descendants

Showing 5 of 11 · See all
  • K123469Powder Free Nitrile Patient Examination Glove, Blue and White Colored, Non-SterileWear Safe (Malaysia) Sdn Bhd - Facility II · 2013 · cites it directly10descendants
  • K142862POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).Careplus (M) Sdn Bhd · 2015 · 2 generations on8descendants
  • K172015Powder Free Nitrile Examination Gloves, Blue (Colored)Careglove Global Sdn. Bhd. · 2017 · 3 generations on5descendants
  • K220442Synguard Nitrile Exam GloveTianjin Aoshang Outdoor Equipment Co., Ltd. · 2022 · 4 generations on2descendants
  • K201857Powder Free Nitrile Examination Glove Black and Dual Color White-BlueCareplus (M) Sdn Bhd · 2021 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201510
201720
202130
202210
202320
202610
FIG. 1 — Lineage of K111772, 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? (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
*K062764Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue ColoredKossan Latex Industries (M)Sdn Bhd2007—

Also cleared against K062764: 1 other device →

What descends from it? (11)

See all 11

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K123469Powder Free Nitrile Patient Examination Glove, Blue and White Colored, Non-SterileWear Safe (Malaysia) Sdn Bhd - Facility II201310

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?

  • Its one ancestor has no recall.
  • Of its descendants, K123469 (Wear Safe (Malaysia) Sdn Bhd - Facility II, 2013) has gone furthest, with 10 descendants of its own.
  • 1 other device also cites its predicate K062764.

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. 2011, 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 as stated in the FDA summary.

Also cleared against K062764

1 other device cites the same predicate.

  • K121947Ets Blue Powder-Free Patient Nitrile Examination GlovesNorthstar Healthcare Holdings · 2012

More from Kossan Latex Industries (M)Sdn Bhd

19 FDA decisions under this applicant name. See the company

  • K123749Powder Free Nitrile Patient Examination Gloves, Green, Non-SterileKossan Latex Industries (M)Sdn Bhd · 2013
  • K120066Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored. Non-Sterile, Low Dermatitis…Kossan Latex Industries (M)Sdn Bhd · 2012
  • K062764Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue ColoredKossan Latex Industries (M)Sdn Bhd · 2007
  • K062965Chlorinated, Polymer-Coated Powder-Free Latex Examination Glove with Protein Labeling ClaimKossan Latex Industries (M)Sdn Bhd · 2006
  • K060775Powder-Free Latex Patient Examination Glove,with Extractable Protein Content Labelling Claim (50 Microgram…Kossan Latex Industries (M)Sdn Bhd · 2006

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/K111772 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111772: Powder Free Nitrile Patient Examination Glove, Blue Colored and White (Non-Colored). Non-Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111772

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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