510(k) · Cleared
ClearedPowder Free Nitrile Examination Gloves, White (Non-Colored) or Blue (Colored), Non-Sterile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wear Safe (Malaysia) Sdn. Bhd. · LZC Medical Glove, Specialty
Cleared on Jan 19, 2010 after a 68-day review. The FDA summary names no predicate by number. 11 later devices descend from it.
- Decided
- Jan 19, 2010
- Review
- 68 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK093500 Powder Free Nitrile Examination Gloves, White (Non-Colored) or Blue…Wear Safe (Malaysia) Sdn. Bhd. · 2010
- 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
- Descendant · 2 generations on · 8 of its ownK142862 POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).Careplus (M) Sdn Bhd · 2015
- Descendant · 3 generations on · 5 of its ownK172015 Powder Free Nitrile Examination Gloves, Blue (Colored)Careglove Global Sdn. Bhd. · 2017
- Descendant · 4 generations on · 2 of its ownK220442 Synguard Nitrile Exam GloveTianjin Aoshang Outdoor Equipment Co., Ltd. · 2022
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093500 | Powder Free Nitrile Examination Gloves, White (Non-Colored) or Blue (Colored)… | Wear Safe (Malaysia) Sdn. Bhd. | 2010 | — |
| +1 | K123469 | Powder Free Nitrile Patient Examination Glove, Blue and White Colored… | Wear Safe (Malaysia) Sdn Bhd - Facility II | 2013 | — |
| +2 | K142862 | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). | Careplus (M) Sdn Bhd | 2015 | — |
| +3 | K172015 | Powder Free Nitrile Examination Gloves, Blue (Colored) | Careglove Global Sdn. Bhd. | 2017 | — |
| +4 | K220442 | Synguard Nitrile Exam Glove | Tianjin Aoshang Outdoor Equipment Co., Ltd. | 2022 | — |
| +3 | K201857 | Powder Free Nitrile Examination Glove Black and Dual Color White-Blue | Careplus (M) Sdn Bhd | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123469 | Powder Free Nitrile Patient Examination Glove, Blue and White Colored, Non-Sterile | 2013 | 10 |
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, K123469 (Wear Safe (Malaysia) Sdn Bhd - Facility II, 2013) has gone furthest, with 10 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. 2010, 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 powder free nitrile examination glove is a disposable device made of synthetic material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants. In addition, this product is tested for use with chemotherapy drugs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093500: Powder Free Nitrile Examination Gloves, White (Non-Colored) or Blue (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/K093500
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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