510(k) · Cleared
ClearedNitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fitone Latex Products Co., Ltd. Guangdong · LZA Polymer Patient Examination Glove
Cleared on Dec 1, 2022 as substantially equivalent to K211220 (Guangdong Kingfa Sci. & Tech.Co., Ltd., 2021) after a 168-day review. Its family tree reaches back 5 generations to 2016.
- Decided
- Dec 1, 2022
- Review
- 168 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K160562 (2016). No later device cites it as a predicate yet.
- 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 deviceK221747 Nitrile Patient Examination Gloves Tested For Use With Chemotherapy…Fitone Latex Products Co., Ltd. Guangdong · 2022
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) | K221747 | Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs | Fitone Latex Products Co., Ltd. Guangdong | 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 |
|---|---|---|---|
| * | K211220 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile…Summary page 5…Review Panel: General Hospital Page 1 of 9 III. Predicate Devices 510(k) Number: K211220 Trade name: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy… | 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 1.4 years on median.
- None of the 5 ancestors has a recall.
- 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 nitrile examination glove is intended to be worn on the examiner’s hand to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carboplatin, 10 mg/ml >240 min. Carmustine (BCNU), 3.3 mg/ml…
Read the full statement (138 words)
The nitrile examination glove is intended to be worn on the examiner’s hand to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:
Carboplatin, 10 mg/ml >240 min.
Carmustine (BCNU), 3.3 mg/ml 27.5 min
Cisplatin, 1.0 mg/ml >240 min
Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 min
Doxorubicin HCI, 2.0 mg/ml >240 min
Etoposide, 20.0 mg/ml >240 min
Fluorouracil, 50.0 mg/ml >240 min
Paclitaxel, 6.0 mg/ml >240 min
Thio Tepa, 10.0 mg/ml 88.2 min
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 27.5 Minutes; Thio Tepa 10.0 mg/ml 88.2 Minutes.
Warning: Please do not use with Carmustine and Thio Tepa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221747 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221747: Nitrile Patient Examination Gloves 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/K221747
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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