510(k) · Cleared
ClearedPowder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koon Seng Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Dec 21, 2021 as substantially equivalent to K192954 (Comfort Rubber Gloves Industries Sdn. Bhd., 2020) after a 125-day review. Its family tree reaches back 2 generations to 2019.
- Decided
- Dec 21, 2021
- Review
- 125 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K183287 (2019). No later device cites it as a predicate yet.
- Root · 2 generations backK183287 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2019
- 1 generation backK192954 Power Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2020
- This deviceK212613 Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use…Koon Seng Sdn Bhd · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2019 | — |
| −1 | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020 | — |
| 0 (this device) | K212613 | Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with… | Koon Seng 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 |
|---|---|---|---|
| * | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and FentanylSummary page 4…duct Codes : LZA, LZC, OPJ, QDO Device Class : Class I 3.0 Predicate: Identification of Legally Marketed Device Predicate 510(k) No. : K192954 Blue Colored, Powder Free Nitrile Examination Gloves Tested for Use with Trade Name… | 2020 |
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 2 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 2 ancestors has a recall.
- 10 other devices also cite its predicate K192954.
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 Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specialty glove has also been tested with Chemotherapy drugs and the Opioid Fentanyl citrate. Chemotherapy Drugs and the opioid Fentanyl citrate were tested for breakthrough detection times: TEST CONCENTRATION MINIMUM BREAKTHROUGH CHEMOTHERAPY DRUG TESTED DETECTION…
Read the full statement (249 words)
A Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specialty glove has also been tested with Chemotherapy drugs and the Opioid Fentanyl citrate.
Chemotherapy Drugs and the opioid Fentanyl citrate were tested for breakthrough detection times:
TEST CONCENTRATION MINIMUM BREAKTHROUGH
CHEMOTHERAPY DRUG TESTED DETECTION TIME (MINUTES)
Carmustine (BCNU) 3.3 mg/mi 13.0
Cisplatin 1.0 mgml No Breakthrough Up To 240 minutes
Cyclophosphamide (Cytoxan) 20.0 mg/ml No Breakthrough Up To 240 minutes
Cylarabine 100.0 mg/ml No Breakthrough Up To 240 minutes
Dacarbazine (DTIC) 10.0 mg/ml No Breakthrough Up To 240 minutes
Doxorubicin Hydrochloride 2.0 mg/mi No Breakthrough Up To 240 minutes
Etoposide (Toposar) 20.0 mg/ml No Breakthrough Up To 240 minutes
Fluorouracil 50.0 mg/ml No Breakthrough Up To 240 minutes
Ifosfamide 50 0 mg/m I No Breakthrough Up To 240 minutes
Methotrexate 25.0 mg/ml No Breakthrough Up To 240 minutes
Mitomycin C 0.5 mg/mI No Breakthrough Up To 240 minutes
Mitoxantrone 2.0 mg/ml No Breakthrough Up To 240 minutes
Paclitaxel (Taxol) 6.0 mgimI No Breakthrough Up To 240 minutes
Thiotepa 10.0 mg/ml 37.9
Vincristine Sulfate 1.0 mg/mi No Breakthrough Up To 240 minutes
Important: Carmustine and Thiotepa have extremely low minimal breakthrough times of
13.0 minutes and 37.9 minutes respectively. Warning: Do not use with Carmustine or Thiotepa.
TEST OPIOID DRUG
Fentanyl Citrate (Injectable)
CONCENTRATION
TESTED
100 0 mg/2ml
I MINIMUM BREAKTHROUGH
DETECTION TIME (MINUTES)
No Breakthrough up to 240 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212613 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212613: Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212613
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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