510(k) · Cleared
ClearedPowder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxter Healthcare, Inc. · LZA Polymer Patient Examination Glove
Cleared on Sep 9, 2026 as substantially equivalent to K213040 (Guangdong Kingfa Sci. & Tech.Co., Ltd., 2022) after a 103-day review. Its family tree reaches back 6 generations to 2016.
- Decided
- Sep 9, 2026
- Review
- 103 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K160562 (2016). No later device cites it as a predicate yet.
- Root · 6 generations backK160562 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP…Hartalega Snd. Bhd. · 2016
- 5 generations backK162982 Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal…Medline Industries, Inc. · 2017
- 4 generations backK180696 Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves…Medline Industries, Inc. · 2018
- 3 generations backK192315 Medline Green Ambidextrous Power-Free Nitrile Examination Gloves…Medline Industries, Inc. · 2020
- 2 generations backK211220 Nitrile Patient Examination Gloves Blue Tested For Use With…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2021
- 1 generation backK213040 Nitrile Patient Examination Gloves Blue Tested For Use With…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022
- This deviceK261793 Powder-free Nitrile Examination Gloves Tested for Use With…Maxter Healthcare, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K160562 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for… | Hartalega Snd. Bhd. | 2016 | — |
| −5 | K162982 | Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP… | Medline Industries, Inc. | 2017 | — |
| −4 | K180696 | Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with… | Medline Industries, Inc. | 2018 | — |
| −3 | K192315 | Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with… | Medline Industries, Inc. | 2020 | — |
| −2 | K211220 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy… | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2021 | — |
| −1 | K213040 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy… | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022 | — |
| 0 (this device) | K261793 | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs… | Maxter Healthcare, Inc. | 2026 | — |
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 |
|---|---|---|---|
| * | K213040 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile…Summary page 9…Device Classification: Class I Product Code: LZA, LZC, OPJ, QDO 5.0 Predicate Device 510(k) Number: K213040 Trade name: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Ni… | 2022 |
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 10 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K213040.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
The Powder-free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue Color), are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile glove. In addition, these gloves were tested Tested for Use with Chemotherapy Drugs and Fentanyl Citrate in accordance with ASTM D6978-05(Re-approved 2023) Standard Practice for Assessment…
Read the full statement (146 words)
The Powder-free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue Color), are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile glove. In addition, these gloves were tested Tested for Use with Chemotherapy Drugs and Fentanyl Citrate in accordance with ASTM D6978-05(Re-approved 2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs
The Powder-free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black Color), are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile glove. In addition, these gloves were tested Tested for Use with Chemotherapy Drugs and Fentanyl Citrate in accordance with ASTM D6978-05(Re-approved 2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs
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/K261793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261793: Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261793
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026