510(k) · Cleared
ClearedNitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pt. Sintong Unigolden Glove · LZA Polymer Patient Examination Glove
Cleared on Oct 26, 2022 as substantially equivalent to K213040 (Guangdong Kingfa Sci. & Tech.Co., Ltd., 2022) after a 13-day review. Its family tree reaches back 6 generations to 2016.
- Decided
- Oct 26, 2022
- Review
- 13 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K160562 (2016). No later device cites it as a predicate yet.
- Root · 6 generations backK160562 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP…Hartalega Snd. Bhd. · 2016
- 5 generations backK162982 Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal…Medline Industries, Inc. · 2017
- 4 generations backK180696 Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves…Medline Industries, Inc. · 2018
- 3 generations backK192315 Medline Green Ambidextrous Power-Free Nitrile Examination Gloves…Medline Industries, Inc. · 2020
- 2 generations backK211220 Nitrile Patient Examination Gloves Blue Tested For Use With…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2021
- 1 generation backK213040 Nitrile Patient Examination Gloves Blue Tested For Use With…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022
- This deviceK223235 Nitrile Examination Gloves Powder Free (Tested for use with…Pt. Sintong Unigolden Glove · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K160562 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for… | Hartalega Snd. Bhd. | 2016 | — |
| −5 | K162982 | Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP… | Medline Industries, Inc. | 2017 | — |
| −4 | K180696 | Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with… | Medline Industries, Inc. | 2018 | — |
| −3 | K192315 | Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with… | Medline Industries, Inc. | 2020 | — |
| −2 | K211220 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy… | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2021 | — |
| −1 | K213040 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy… | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022 | — |
| 0 (this device) | K223235 | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) | Pt. Sintong Unigolden Glove | 2022 | — |
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 |
|---|---|---|---|
| * | K213040 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile…Summary page 5…Nitrile Patient Examination Gloves Blue Colored Tested For Use With Chemotherapy Drugs 510(k) Number K213040 Regulatory Class Class 1 Product code LZA, LZC, OPJ Reference Device… | 2022 |
| † | K210388 | Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color | 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?
- The line of descent spans 6 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K213040.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This is a single-use…
Read the full statement (273 words)
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This is a single-use, powder-free, non-sterile device.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes
Carboplatin 10 mg/ml (10,000 ppm) > 240 Minutes
Carmustine 3.3 mg/ml (3,300 ppm) 15.9 Minutes
Cisplatin 1 mg/ml (1,000 ppm) > 240 Minutes
Cyclophosphamide 20 mg/ml (20,000 ppm) > 240 Minutes
Cytarabine HCI 100 mg/ml (100,000 ppm) > 240 Minutes
Dacarbazine 10 mg/ml (10,000 ppm) > 240 Minutes
Docetaxel 10 mg/ml (10,000 ppm) > 240 Minutes
Doxorubicin HCI 2 mg/ml (2,000 ppm) > 240 Minutes
Etoposide 20 mg/ml (20,000 ppm) > 240 Minutes
Fluorouracil 50 mg/ml (50,000 ppm) > 240 Minutes
Gemcitabine 38 mg/ml (38,000 ppm) > 240 Minutes
Ifosfamide 50 mg/ml (50,000 ppm) > 240 Minutes
Irinotecan 20 mg/ml (20,000 ppm) > 240 Minutes
Mechlorethamine HCl 1 mg/ml (1,000 ppm) > 240 Minutes
Melphalan 5 mg/ml (5,000 ppm) > 240 Minutes
Methotrexate 25 mg/ml (25,000 ppm) > 240 Minutes
Mitoxantrone 2 mg/ml (2,000 ppm) > 240 Minutes
Paclitaxel 6 mg/ml (6,000 ppm) > 240 Minutes
Thiotepa 10 mg/ml (10,000 ppm) 54.2 Minutes
Please note that the following drugs have low permeation times:
Carmustine 3.3 mg/ml 15.9 Minutes
Thiotepa 10 mg/ml 54.2 Minutes
Warning: Please do not use with Carmustine and Thiotepa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223235: Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223235
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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