510(k) · Cleared
ClearedPowder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue Colored
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kossan Latex Industries (M)Sdn Bhd · LZC Medical Glove, Specialty
Cleared on Feb 27, 2007 after a 165-day review. The FDA summary names no predicate by number. 18 later devices descend from it.
- Decided
- Feb 27, 2007
- Review
- 165 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 2 citing it directly.
- This deviceK062764 Powder-Free Nitrile Patient Examination Glove, White (Non-Colored)…Kossan Latex Industries (M)Sdn Bhd · 2007
- Descendant · cites it directly · 11 of its ownK111772 Powder Free Nitrile Patient Examination Glove, Blue Colored and…Kossan Latex Industries (M)Sdn Bhd · 2011
- Descendant · 2 generations on · 10 of its ownK123469 Powder Free Nitrile Patient Examination Glove, Blue and White…Wear Safe (Malaysia) Sdn Bhd - Facility II · 2013
- Descendant · 3 generations on · 8 of its ownK142862 POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).Careplus (M) Sdn Bhd · 2015
- Descendant · 4 generations on · 5 of its ownK172015 Powder Free Nitrile Examination Gloves, Blue (Colored)Careglove Global Sdn. Bhd. · 2017
- Descendant · cites it directly · 5 of its ownK121947 Ets Blue Powder-Free Patient Nitrile Examination GlovesNorthstar Healthcare Holdings · 2012
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K111772Powder Free Nitrile Patient Examination Glove, Blue Colored and White (Non-Colored).…Kossan Latex Industries (M)Sdn Bhd · 2011 · cites it directly11descendants
- K123469Powder Free Nitrile Patient Examination Glove, Blue and White Colored, Non-SterileWear Safe (Malaysia) Sdn Bhd - Facility II · 2013 · 2 generations on10descendants
- K142862POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).Careplus (M) Sdn Bhd · 2015 · 3 generations on8descendants
- K172015Powder Free Nitrile Examination Gloves, Blue (Colored)Careglove Global Sdn. Bhd. · 2017 · 4 generations on5descendants
- K121947Ets Blue Powder-Free Patient Nitrile Examination GlovesNorthstar Healthcare Holdings · 2012 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062764 | Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue… | Kossan Latex Industries (M)Sdn Bhd | 2007 | — |
| +1 | K111772 | Powder Free Nitrile Patient Examination Glove, Blue Colored and White… | Kossan Latex Industries (M)Sdn Bhd | 2011 | — |
| +2 | K123469 | Powder Free Nitrile Patient Examination Glove, Blue and White Colored… | Wear Safe (Malaysia) Sdn Bhd - Facility II | 2013 | — |
| +3 | K142862 | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). | Careplus (M) Sdn Bhd | 2015 | — |
| +4 | K172015 | Powder Free Nitrile Examination Gloves, Blue (Colored) | Careglove Global Sdn. Bhd. | 2017 | — |
| +1 | K121947 | Ets Blue Powder-Free Patient Nitrile Examination Gloves | Northstar Healthcare Holdings | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2026 | 1 | 0 |
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 LZC? 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 LZC device
- #1 K201390 Medline Powder-Free Light Blue Nitrile Exam…score 19.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (18)
See all 182 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K111772 (Kossan Latex Industries (M)Sdn Bhd, 2011) has gone furthest, with 11 descendants of its own.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LZC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZC
85in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZC
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZC
10in 2025
MAUDE reports naming product code LZC, 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 | 0 |
| 2008 | 3 | 166 | 1 | 0 |
| 2009 | 5 | 253 | 0 | 1 |
| 2010 | 5 | 68 | 0 | 0 |
| 2011 | 0 | — | 4 | 1 |
| 2012 | 4 | 149 | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 258 | 0 | 5 |
| 2017 | 6 | 121 | 0 | 7 |
| 2018 | 6 | 105 | 0 | 6 |
| 2019 | 7 | 200 | 0 | 8 |
| 2020 | 3 | 167 | 0 | 1 |
| 2021 | 3 | 94 | 1 | 2 |
| 2022 | 7 | 85 | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 1 | — | 1 | — |
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 or finger to prevent contamination between patient and examiner.
This device is not intended to be used as a chemical barrier.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062764 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062764: Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue Colored.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062764
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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