510(k) · Cleared
ClearedNitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Kingfa Sci. & Tech.Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Apr 27, 2022 as substantially equivalent to K211220 (Guangdong Kingfa Sci. & Tech.Co., Ltd., 2021) after a 217-day review. Its family tree reaches back 5 generations to 2016. 3 later devices descend from it.
- Decided
- Apr 27, 2022
- Review
- 217 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K160562 (2016). 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK160562 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP…Hartalega Snd. Bhd. · 2016
- 4 generations backK162982 Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal…Medline Industries, Inc. · 2017
- 3 generations backK180696 Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves…Medline Industries, Inc. · 2018
- 2 generations backK192315 Medline Green Ambidextrous Power-Free Nitrile Examination Gloves…Medline Industries, Inc. · 2020
- 1 generation backK211220 Nitrile Patient Examination Gloves Blue Tested For Use With…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2021
- This deviceK213040 Nitrile Patient Examination Gloves Blue Tested For Use With…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK261793 Powder-free Nitrile Examination Gloves Tested for Use With…Maxter Healthcare, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK223235 Nitrile Examination Gloves Powder Free (Tested for use with…Pt. Sintong Unigolden Glove · 2022
- Descendant · cites it directly · 0 of its ownK222714 Nitrile Patient Examination Gloves Blue Tested For Use With…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See all- K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and…Maxter Healthcare, Inc. · 2026 · cites it directly0descendants
- K223235Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)Pt. Sintong Unigolden Glove · 2022 · cites it directly0descendants
- K222714Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K160562 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for… | Hartalega Snd. Bhd. | 2016 | — |
| −4 | K162982 | Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP… | Medline Industries, Inc. | 2017 | — |
| −3 | K180696 | Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with… | Medline Industries, Inc. | 2018 | — |
| −2 | K192315 | Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with… | Medline Industries, Inc. | 2020 | — |
| −1 | K211220 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy… | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2021 | — |
| 0 (this device) | K213040 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy… | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022 | — |
| +1 | K261793 | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs… | Maxter Healthcare, Inc. | 2026 | — |
| +1 | K223235 | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) | Pt. Sintong Unigolden Glove | 2022 | — |
| +1 | K222714 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy… | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K211220 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile…Summary page 7…ory Class: Class I Product code: LZA, LZC,OPJ, QDO Review Panel General Hospital III. Predicate Devices 510(k) Number: K211220 Trade name: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs… | 2021 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261793 | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and… | 2026 | 0 |
| K223235 | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) | 2022 | 0 |
| K222714 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile… | 2022 | 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 6 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K261793 (Maxter Healthcare, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K211220.
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?
The blue colored nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device. The Nitrile Patient Examination Gloves Blue Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The tested chemotherapy drug are as…
Read the full statement (432 words)
The blue colored nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The Nitrile Patient Examination Gloves Blue Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The tested chemotherapy drug are as follows:
• Bleomycin Sulfate 15 mg/ml >240 min.
• Carboplatin 10 mg/ml >240 min.
• Carmustine (BCNU) 3.3 mg/ml 17.2 min.
• Cisplatin 1.0 mg/ml >240 min.
• Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min.
• Cytarabine HCI 100 mg/ml >240 min.
• Dacarbazine (DTIC)lO.0 mg/ml >240 min.
• Daunorubicin 5.0 mg/ml >240 min.
• Docetaxel 10.0 mg/ml >240 min
• Doxorubicin HCI 2.0 mg/ml >240 min.
• Etoposide (Toposar) 20.0 mg/ml >240 min.
• Fluorouracil 50.0 mg/ml >240 min.
• Gemcitabine 38 mg/ml>240 min.
• Idarubicin 1 mg/ml >240 min.
• lfosfamide 50.0 mg/ml >240 min.
• Irinotecan 20.0 mg/ml >240 min.
• Mechlorethamine HCI 1.0 mg/ml>240 min.
• Melphalan 5 mg/ml >240 min.
• Methotrexate 25 mg/ml >240 min.
• Mitromycin C. 0.5 mg/ml >240
• Mitoxantrone 2.0 mg/ml >240 min.
• Paclitaxel (Taxol) 6.0 mg/ml >240 min.
• Thiotepa 10.0 mg/ml 13.9 min.
• Vincristine Sulfate 1.0 mg/ml >240 min.
Warning: Do not use with Carmustine and Thiotepa.
The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The Nitrile Patient Examination Gloves Blue Violet Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The tested chemotherapy drug are as follows:
• Carmustine (BCNU) 3.3 mg/ml 65.3 min.
• Cisplatin 1.0 mg/ml >240 min.
• Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min.
• Dacarbazine (DTIC)lO.0 mg/ml >240 min.
• Doxorubicin HCI 2.0 mg/ml >240 min.
• Etoposide (Toposar) 20.0 mg/ml >240 min.
• Fluorouracil 50.0 mg/ml >240 min.
• Methotrexate 25 mg/ml >240 min.
• Paclitaxel (Taxol) 6.0 mg/ml >240 min.
• Thiotepa 10.0 mg/ml 58.3 min.
Waming: Do not use with Carmustine and Thiotepa.
The nitrile examination glove is intended to be worn on the hands of examiner’s to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The Nitrile Patient Examination Gloves Black Colored were tested for use with Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
* Fentanyl Citrate 100mcg/2ml >240 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/K213040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213040: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black 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/K213040
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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