510(k) · Cleared
ClearedGLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Glove One, LLC · LZA Polymer Patient Examination Glove
Cleared on Jun 3, 2025 as substantially equivalent to K193666 (Medline Industries, Inc., 2020) after a 175-day review. Its family tree reaches back 4 generations to 2009.
- Decided
- Jun 3, 2025
- Review
- 175 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K082957 (2009). No later device cites it as a predicate yet.
- Root · 4 generations backK082957 Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color…Siam Sempermed Corp., Ltd. · 2009
- 3 generations backK101822 Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for…Sgmp Co., Ltd. · 2010
- 2 generations backK111248 Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue…Yty Industry (Manjung) Sdn Bhd · 2011
- 1 generation backK193666 Powder-Free Blue Nitrile Examination Gloves (Tested for use with…Medline Industries, Inc. · 2020
- This deviceK243796 GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile…Glove One, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K082957 | Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color, Polymer… | Siam Sempermed Corp., Ltd. | 2009 | — |
| −3 | K101822 | Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for Use with… | Sgmp Co., Ltd. | 2010 | — |
| −2 | K111248 | Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) | Yty Industry (Manjung) Sdn Bhd | 2011 | — |
| −1 | K193666 | Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy… | Medline Industries, Inc. | 2020 | — |
| 0 (this device) | K243796 | GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use… | Glove One, LLC | 2025 | — |
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 |
|---|---|---|---|
| * | K193666 | Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and…Summary page 6…ital Regulation #: 21 CFR 880.6250 Predicate Device Medline Powder-Free Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)- Regular Cuff – K193666 Product Code: LZA, OPJ, QDO Applicant Name: Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093… | 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 16 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- None of the 4 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. 2025, 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. These gloves were tested for use with chemotherapy drugs and fentanyl citrate per ASTM D6978-05 (Reapproved 2019) Standard Practices for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug Tested Breakthrough Time (minutes) Cisplatin 1 mg/ml (1,000 ppm)…
Read the full statement (184 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. These gloves were tested for use with chemotherapy drugs and
fentanyl citrate per ASTM D6978-05 (Reapproved 2019) Standard Practices for Assessment of Medical Gloves to
Permeation by Chemotherapy Drugs.
Chemotherapy Drug Tested Breakthrough Time (minutes)
Cisplatin 1 mg/ml (1,000 ppm) >240 min
Cyclophosphamide 20 mg/m1l (20,000 ppm) >240 min
Dacarbazine 10 mg/ml (10,000 ppm) >240 min
Doxorubicin HCL 2 mg/ml (2,000 ppm) >240 min
Etoposide 20 mg/ml (20,000 ppm) >240 min
Fluorouracil 50 mg/ml (50,000 ppm) >240 min
Ifosamide 50 mg/ml (50,000 ppm) >240 min
Mitroxantrone HCL 2 mg/ml (2,000 ppm) >240 min
Paclitaxel 6 mg/ml (16,000 ppm) >240 min
Vincristine Sulfate 1 mg/ml (1,000 ppm) >240 min
Carmustine 3.3 mg/ml (3,000 ppm) 12.3 minutes
Thiotepa 10 mg/ml (10,000 ppm) > 240 min 13.4 minutes
Fentanyl Tested Breakthrough Time (minutes)
Fentanyl Citrate Injection, 100 mcg/2 mL >240 min
WARNING: The following drugs have low permeation times:
Carmustine (BCNU) (3.3 mg/ml) 12.3 minutes
Thiotepa (THT) (10.0 mg/ml) 13.4 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/K243796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243796: GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl].” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243796
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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