510(k) · Cleared
ClearedNon-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yty Industry (Manjung) Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Aug 25, 2017 as substantially equivalent to K161215 (Brightway Holdings Sdn. Bhd., 2016) after a 134-day review. Its family tree reaches back 3 generations to 2009.
- Decided
- Aug 25, 2017
- Review
- 134 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K090412 (2009). No later device cites it as a predicate yet.
- Root · 3 generations backK090412 Powder Free Nitrile Examination Gloves (Pink, Green, Orange,White).Gx Corporation Sdn Bhd · 2009
- 2 generations backK151750 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2016
- 1 generation backK161215 Brightway Brand Nitrile Examination Gloves, Powder Free…Brightway Holdings Sdn. Bhd. · 2016
- This deviceK171104 Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use…Yty Industry (Manjung) Sdn Bhd · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K090412 | Powder Free Nitrile Examination Gloves (Pink, Green, Orange,White). | Gx Corporation Sdn Bhd | 2009 | — |
| −2 | K151750 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2016 | — |
| −1 | K161215 | Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey]… | Brightway Holdings Sdn. Bhd. | 2016 | — |
| 0 (this device) | K171104 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with… | Yty Industry (Manjung) Sdn Bhd | 2017 | — |
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 |
|---|---|---|---|
| * | K161215 | Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use…Summary page 5…s, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs Predicate 510(K) K161215 number: Device Classification: I Product Code: LZC… | 2016 |
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 8 years and passes through 4 companies; a new generation was cleared every 8 months on median.
- None of the 3 ancestors has a 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. 2017, 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 gloves 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. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below. Tested Chemotherapy Drug And Concentration — Average Breakthrough Detection Time Carboplatin, 10 mg/ml — > 240 minutes Carmustine (3.3 mg/ml) —…
Read the full statement (383 words)
A patient examination gloves 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. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
Tested Chemotherapy Drug And Concentration — Average Breakthrough Detection Time
Carboplatin, 10 mg/ml — > 240 minutes
Carmustine (3.3 mg/ml) — 15.0 minutes
Cisplatin (BCNU), 1.0 mg/ml — > 240 minutes
Cyclophosphamide (Cytoxan), 20.0 mg/ml — > 240 minutes
Dacarbazine (DTIC), 10.0 mg/ml — > 240 minutes
Doxorubicin Hydrochloride, 2.0 mg/ml — > 240 minutes
Etoposide (Toposar), 20.0 mg/ml — > 240 minutes
Fluorouracil, 50.0 mg/ml — > 240 minutes
Ifosfamide , 50.0 mg/ml — > 240 minutes
Methotrexate, 25 mg/ml — > 240 minutes
Mitomycin C, 0.5 mg/ml — > 240 minutes
Mitoxantrone, 2 mg/ml — > 240 minutes
Paclitaxel (Taxol), 6.0 mg/ml — > 240 minutes
ThioTEPA (10.0 mg/ml) — 30.1minutes
Vincristine Sulfate, 1.0 mg/ml — > 240 minutes
The following chemotherapy drugs and concentration have extremely low permeation time.
Carmustine (3.3 mg/ml): 15.0 minutes ThioTEPA (10.0 mg/ml): 30.1 minutes
A patient examination gloves 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. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
Tested Chemotherapy Drug And Concentration — Average Breakthrough Detection Time
Carboplatin, 10 mg/ml — > 240 minutes
Carmustine (3.3 mg/ml) — 2.4 minutes
Cisplatin (BCNU), 1.0 mg/ml — > 240 minutes
Cyclophosphamide (Cytoxan), 20.0 mg/ml — > 240 minutes
Dacarbazine (DTIC), 10.0 mg/ml — > 240 minutes
Doxorubicin Hydrochloride, 2.0 mg/ml — > 240 minutes
Etoposide (Toposar), 20.0 mg/ml — > 240 minutes
Fluorouracil, 50.0 mg/ml — > 240 minutes
Ifosfamide , 50.0 mg/ml — > 240 minutes
Methotrexate, 25 mg/ml — > 240 minutes
Mitomycin C, 0.5 mg/ml — > 240 minutes
Mitoxantrone, 2 mg/ml — > 240 minutes
Paclitaxel (Taxol), 6.0 mg/ml — > 240 minutes
ThioTEPA (10.0 mg/ml) — 1.9 minutes
Vincristine Sulfate, 1.0 mg/ml — > 240 minutes
The following chemotherapy drugs and concentration have extremely low permeation time.
Carmustine (3.3 mg/ml): 2.4 minutes ThioTEPA (10.0 mg/ml): 1.9 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171104 · printed Nov 5, 2026
Cite this page
510(k) Report. “K171104: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K171104
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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