510(k) · Cleared
ClearedPowder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · LZA Polymer Patient Examination Glove
Cleared on Aug 4, 2020 as substantially equivalent to K111248 (Yty Industry (Manjung) Sdn Bhd, 2011) after a 217-day review. Its family tree reaches back 3 generations to 2009. 1 later device descends from it.
- Decided
- Aug 4, 2020
- Review
- 217 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K082957 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK082957 Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color…Siam Sempermed Corp., Ltd. · 2009
- 2 generations backK101822 Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for…Sgmp Co., Ltd. · 2010
- 1 generation backK111248 Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue…Yty Industry (Manjung) Sdn Bhd · 2011
- This deviceK193666 Powder-Free Blue Nitrile Examination Gloves (Tested for use with…Medline Industries, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK243796 GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile…Glove One, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K243796GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with…Glove One, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K082957 | Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color, Polymer… | Siam Sempermed Corp., Ltd. | 2009 | — |
| −2 | K101822 | Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for Use with… | Sgmp Co., Ltd. | 2010 | — |
| −1 | K111248 | Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) | Yty Industry (Manjung) Sdn Bhd | 2011 | — |
| 0 (this device) | K193666 | Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy… | Medline Industries, Inc. | 2020 | — |
| +1 | K243796 | GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use… | Glove One, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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 |
|---|---|---|---|
| * | K111248 | Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue)Summary page 7…n #: 21 CFR 880.6250 Predicate Device YTY Industry (Manjung): Non-Sterile, Powder-Free Nitrile Examination Gloves (Cobalt Blue) Tested for use with Chemotherapy Drugs – K111248 Page 1 of 28 Medline Industries, Inc.… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243796 | GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with… | 2025 | 0 |
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 11 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K243796 (Glove One, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K111248.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Chemo Drugs Tested: Breakthrough Time (Minutes) Aresenic Trioxide 1 mg/ml (1,000 ppm) >240 Azacitidine 25 mg/ml (25,000 ppm) >240 Bendamustine 5 mg/ml (5,000 ppm) >240 Bleomycin 15 mg/ml (15,000 ppm) >240 Bortezomib 1 mg/ml (1,000 ppm) >240 Busulfan 6 mg/ml (6,000 ppm) >240 Carboplatin…
Read the full statement (681 words)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Chemo Drugs Tested: Breakthrough Time (Minutes)
Aresenic Trioxide 1 mg/ml (1,000 ppm) >240
Azacitidine 25 mg/ml (25,000 ppm) >240
Bendamustine 5 mg/ml (5,000 ppm) >240
Bleomycin 15 mg/ml (15,000 ppm) >240
Bortezomib 1 mg/ml (1,000 ppm) >240
Busulfan 6 mg/ml (6,000 ppm) >240
Carboplatin 10.0 mg/ml (10,000 ppm) >240
Carfilzomib 2.0 mg/ml (2,000) >240
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 33.1 min
Cetuximab 2.0 mg/ml (2,000) >240
Cisplatin 1.0 mg/ml (1,000 ppm) >240
Cyclophosphamide (Cytoxan) 20.0 mg/ml (20,000 ppm) >240
Cytarabine 100 mg/ml (100,000 ppm) >240
Cytovene 10 mg/ml (10,000 ppm) >240
Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) >240
Daunorubicin 5 mg/ml (5,000 ppm) >240
Decitabine 5 mg/ml (5,000 ppm) >240
Docetaxel 10.0 mg/ml (10,000 ppm) >240
Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) >240
Epirubicin (Ellence) 2.0 mg/ml (2,000 ppm) >240
Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) >240
Fludarabine 25 mg/ml (25,000 ppm) >240
Fluorouracil 50.0 mg/ml (50,000 ppm) >240
Fulvestrant 50.0 mg/ml (50,000 ppm) >240
Gemcitabine (Gemzar) 38 mg/ml (38,000 ppm) >240
Idarubicin 1 mg/ml (1,000 ppm) >240
lfosfamide 50.0 mg/ml (50,000 ppm) >240
Irinotecan 20.0 mg/ml (20,000 ppm) >240
Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) >240
Melphalan 5 mg/ml (5,000 ppm) >240
Methotrexate 25 mg/ml (25,000 ppm) >240
Mitomycin C 0.5 mg/ml (500 ppm) >240
Mitoxantrone 2.0 mg/ml (2,000 ppm) >240
Oxaliplatin 2.0 mg/ml (2,000 ppm) >240
Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) >240
Paraplatin 10 mg/ml (10,000 ppm) >240
Pemetrexed Disodium 25.0 mg/ml (25,000 ppm) >240
Pertuzumab 30 mg/ml (30,000 ppm) >240
Raltitrexed 0.5 mg/ml (500 ppm) >240
Retrovir 10.0 mg/ml (10,000 ppm) >240
Rituximab 10 mg (10,000 ppm) >240
Temsirolimus 25.0 mg/ml (25,000 ppm) >240
Thiotepa 10.0 mg/ml (10,000 ppm) 69.2 min
Topotecan HCI 1.0 mg/ml (1,000 ppm) >240
Trastuzumab 21.0 mg/ml (21,000 ppm) >240
Trisonex 1 mg/ml (1,000 ppm) >240
Vinblastine 1 mg/ml (1,000 ppm) >240
Vincristine Sulfate 1.0 mg/ml (1,000 ppm) >240
Vinorelbine 10 mg/ml (10,000 ppm) >240
Zoledronic Acid 0.8 mg/ml (800 ppm) >240
Fentanyl Citrate, 100mcg/2mL >240min
62.0
Please note that the following drug has low permeation time:
Carmustine (BCNU) (3.3 mg/ml) 33.1 minutes
Thiotepa (THT) (10.0mg/ml) 69.2 minutes
CAUTION: Testing showed an average breakthrough time of33.l minutes with Carmustine and 69.2 minutes with Thiotepa
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand to
prevent contamination between patient and examiner.
Chemotherapy Drug Tested Breakthrough Time (in minutes)
Aresenic Trioxide 1 mg/ml >240
Azacitidine 25 mg/ml >240
Bendamustine 5 mg/ml >240
Bleomycin 15 mg/m >240
Bortezomib 1 mg/ml >240
Busulfan 6 mg/ml >240
Carfilzomib 2 mg/ml >240
Carmustine (BCNU) 3.3 mg/ml 59.4 min
Cetuximab >240
Cisplatin 1.0 mg/ml >240
Cyclophosphamide (Cytoxan) 20.0 mg/ml >240
Cytarabine Hydrochloride 100 mg/ml >240
Cytovene 10 mg/ml >240
Dacarbazine (DTIC) 10.0 mg/ml >240
Daunorubicin 5 mg/ml >240
Decitabine 5 mg/ml >240
Docetaxel 10.0 mg/ml >240
Doxorubicin Hydrochloride 2.0 mg/ml >240
Epirubicin (Ellence) 2.0 mg/ml >240
Etoposide (Toposar) 20.0 mg/ml >240
Fludarabine 25 mg/ml >240
Fluorouracil 50.0 mg/ml >240
Fulvestrant 50.0 mg/ml >240
Gemcitabine (Gemzar) 38 mg/ml >240
Idarubicin 1 mg/ml >240
Ifosfamide 50.0 mg/ml >240
Irinotecan 20.0 mg/ml >240
Mechlorethamine HCI 1.0 mg/ml >240
Melphalan 5 mg/ml >240
Methotrexate 25.0 mg/ml >240
Mitomycin C 0.5 mg/ml >240
Mitoxantrone 2mg/ml >240
Oxaliplatin 5.0 mg/ml >240
Paclitaxel (Taxol) 6.0 mg/ml >240
Paraplatin (Carboplatin) 10 mg/ml >240
Pemetrexed Disodium 25.0 mg/ml >240
Pertuzumab 30 mg/ml >240
Raltitrexed 0.5 mg/ml >240
Retrovir 10.0 mg/ml >240
Rituximab 10 mg/ml >240
Temsirolimus 25.0 mg/ml >240
Thiotepa 10.0 mg/ml 68.2 min
Topotecan HCI 1.0 mg/ml >240
Trastuzumab 21.0 mg/ml >240
Trisonex 1 mg/ml >240
Vinblastine 1 mg/ml >240
Vincristine Sulfate 1.0 mg/ml >240
Vinorelbine 10 mg/ml >240
Zoledronic Acid 0.8 mg/ml >240
Fentanyl Citrate, 100mcg/2mL >240
167.8 min
Please note that the following drug has low permeation time:
Carmustine (BCNU) (3 .3 mg/ml) 59 .4 minutes
Thiotepa (THT) (10.0 mg/ml) 68.2 minutes
CAUTION: Testing showed an average breakthrough time of 59.4 minutes with Carmustine and 68.2 minutes with Thiotepa
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/K193666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193666: Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193666
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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