510(k) · Cleared
ClearedNitrile Powder Free Blue Examination Gloves, Non-Sterile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mah Sing Healthcare Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Dec 4, 2021 as substantially equivalent to K210369 (Pastel Glove Sdn Bhd, 2021) after a 115-day review. Its family tree reaches back 2 generations to 2016.
- Decided
- Dec 4, 2021
- Review
- 115 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K153562 (2016). No later device cites it as a predicate yet.
- Root · 2 generations backK153562 Powder Free Blue Nitrile Examination GloveVietglove Corporation · 2016
- 1 generation backK210369 Powder Free Nitrile Examination GlovePastel Glove Sdn Bhd · 2021
- This deviceK212535 Nitrile Powder Free Blue Examination Gloves, Non-SterileMah Sing Healthcare Sdn. Bhd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K153562 | Powder Free Blue Nitrile Examination Glove | Vietglove Corporation | 2016 | — |
| −1 | K210369 | Powder Free Nitrile Examination Glove | Pastel Glove Sdn Bhd | 2021 | — |
| 0 (this device) | K212535 | Nitrile Powder Free Blue Examination Gloves, Non-Sterile | Mah Sing Healthcare Sdn. Bhd. | 2021 | — |
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 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K210369 | Powder Free Nitrile Examination GloveSummary page 4…Product Code: LZA 5.0 Identification of Predicate Device Name: Powder Free Nitrile Examination Gloves The Legally Marketed Predicate 510(K) Number: K210369 Device Manufacture’s Name: Pastel Glove Sdn Bhd 6.0 Description of Device Nitrile Powder Free Blue E… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K210369.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LZA
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZA
110in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZA
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZA
73in 2025
MAUDE reports naming product code LZA, 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 | 21 | 95 | 0 | 7 |
| 2008 | 18 | 97 | 0 | 2 |
| 2009 | 28 | 112 | 0 | 12 |
| 2010 | 31 | 97 | 0 | 12 |
| 2011 | 26 | 122 | 0 | 9 |
| 2012 | 33 | 110 | 0 | 11 |
| 2013 | 20 | 130 | 0 | 10 |
| 2014 | 27 | 197 | 0 | 8 |
| 2015 | 20 | 112 | 1 | 12 |
| 2016 | 30 | 171 | 1 | 25 |
| 2017 | 44 | 124 | 0 | 4 |
| 2018 | 22 | 178 | 0 | 3 |
| 2019 | 25 | 212 | 0 | 21 |
| 2020 | 30 | 101 | 0 | 4 |
| 2021 | 139 | 111 | 0 | 20 |
| 2022 | 146 | 111 | 0 | 19 |
| 2023 | 62 | 92 | 0 | 24 |
| 2024 | 30 | 89 | 0 | 76 |
| 2025 | 24 | 110 | 0 | 73 |
| 2026 | 15 | 103 | 3 | — |
What is it indicated for?
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner’s hand or finger 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.
https://510kreport.com/device/K212535 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212535: Nitrile Powder Free Blue Examination Gloves, Non-Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212535
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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