510(k) · Cleared
ClearedNitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gmp Medicare Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Sep 8, 2026 as substantially equivalent to K202003 (Gmp Medicare Sdn. Bhd., 2021) after a 221-day review. Its family tree reaches back 1 generation to 2021.
- Decided
- Sep 8, 2026
- Review
- 221 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K202003 (2021). No later device cites it as a predicate yet.
- Root · 1 generation backK202003 Nitrile Powder Free Examination Glove, Blue Tested for Use with 32…Gmp Medicare Sdn. Bhd. · 2021
- This deviceK260312 Nitrile Powder Free Examination Glove, Blue Tested for Use with 32…Gmp Medicare Sdn. Bhd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K202003 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32… | Gmp Medicare Sdn. Bhd. | 2021 | — |
| 0 (this device) | K260312 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32… | Gmp Medicare Sdn. Bhd. | 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 |
|---|---|---|---|
| * | K202003 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs…Summary page 8…Drugs and Fentanyl Permeation Resistance Claim 510 (k) Number K202003 Company Name GMP Medicare Sdn. Bhd. Page 1 of 28… | 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?
- Its one ancestor has no recall.
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?
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. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 standard practice for assessment of medical gloves to permeation by chemotherapy drugs: Chemotherapy Drug Permeation The following chemicals have been tested with these gloves. Chemotherapy Drugs…
Read the full statement (626 words)
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.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 standard practice for assessment of medical gloves to permeation by chemotherapy drugs:
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves.
Chemotherapy Drugs Concentration Breakthrough Detection Time in Minutes
Amethopterin 25.0 mg/ml > 240
Bleomycin Sulfate 15.0 mg/ml > 240
Busulfan 6.0 mg/ml > 240
Carboplatin 10.0 mg/ml > 240
Carmustine (BCNU) 3.3 mg/ml 11.0
Cisplatin 1.0 mg/ml > 240
Cyclophosphamide (Cytoxan) 20.0 mg/ml > 240
Cytarabine 100.0mg/ml > 240
Dacarbazine (DTIC) 10.0 mg/ml > 240
Docetaxel 10.0mg/ml > 240
Doxorubicin Hydrochloride 2.0 mg/ml > 240
Ellence 2.0 mg/ml > 240
Etoposide 20.0 mg/ml > 240
Fludarabine 25.0 mg/ml > 240
Fluorouracil 50.0 mg/ml > 240
Gemcitabine 38.0 mg/ml > 240
Idarubicin 1.0 mg/ml > 240
Ifosfamide 50.0 mg/ml > 240
Irinotecan 20.0 mg/ml > 240
Mechlorethamine 1.0 mg/ml > 240
Melphalan 5.0 mg/ml > 240
Methotrexate 25.0 mg/ml > 240
Mitomycin C 0.5 mg/ml > 240
Mitoxantrone 2.0 mg/ml > 240
Oxaliplatin 5.0 mg/ml > 240
Paclitaxel 6.0 mg/ml > 240
Rituximab 10.0 mg/ml > 240
Thiotepa 10.0 mg/ml 39.0
Topotecan 1.0 mg/ml > 240
Trisenox 1.0 mg/ml > 240
Vincristine Sulfate 1.0 mg/ml > 240
Vinorelbine 10.0 mg/ml > 240
Please note that Carmustine and Thiotepa have extremely low permeation times of 11 minutes and 39 minutes respectively.
Warning: Do not use with Carmustine and Thiotepa
Fentanyl Permeation Resistance Claim- Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2ml) was found to have no breakthrough detected up to 240 minutes.
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.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 standard practice for assessment of medical gloves to permeation by chemotherapy drugs:
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves.
Chemotherapy Drugs Concentration Breakthrough Detection Time in Minutes
Amethopterin 25.0 mg/ml > 240
Bleomycin Sulfate 15.0 mg/ml > 240
Busulfan 6.0 mg/ml > 240
Carboplatin 10.0 mg/ml > 240
Carmustine (BCNU) 3.3 mg/ml 10.0
Cisplatin 1.0 mg/ml > 240
Cyclophosphamide (Cytoxan) 20.0 mg/ml > 240
Cytarabine 100.0mg/ml > 240
Dacarbazine (DTIC) 10.0 mg/ml > 240
Docetaxel 10.0mg/ml > 240
Doxorubicin Hydrochloride 2.0 mg/ml > 240
Epirubicin 2.0 mg/ml > 240
Etoposide 20.0 mg/ml > 240
Fludarabine 25.0 mg/ml > 240
Fluorouracil 50.0 mg/ml > 240
Gemicitabine 38.0 mg/ml > 240
Idarubicin 1.0 mg/ml > 240
Ifosfamide 50.0 mg/ml > 240
Irinotecan 20.0 mg/ml > 240
Mechlorethamine 1.0 mg/ml > 240
Melphalan 5.0 mg/ml > 240
Methotrexate 25.0 mg/ml > 240
Mitomycin C 0.5 mg/ml > 240
Mitoxantrone 2.0 mg/ml > 240
Oxaliplatin 5.0 mg/ml > 240
Paclitaxel 6.0 mg/ml > 240
Rituximab 10.0 mg/ml > 240
Thiotepa 10.0 mg/ml 30.0
Topotecan 1.0 mg/ml > 240
Trisenox 1.0 mg/ml > 240
Vincristine Sulfate 1.0 mg/ml > 240
Vinorelbine 10.0 mg/ml > 240
Please note that Carmustine and Thiotepa have extremely low permeation times of 10 minutes and 30 minutes respectively.
Warning: Do not use with Carmustine and Thiotepa
Gastric Acid Permeation Resistance Claim- Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.
Xylazine Permeation Resistance Claim- Under the testing conditions of ASTM D6978-05, Xylazine HCI Injection (100 mg/ml) was found to have no breakthrough detected up to 240 minutes.
Fentanyl Permeation Resistance Claim- Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2ml) was found to have no breakthrough detected up to 240 minutes.
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/K260312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260312: Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260312
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