510(k) · Cleared
ClearedPowder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encompass Industries Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on May 27, 2022 as substantially equivalent to K200181 (Comfort Rubber Gloves Industries Sdn. Bhd., 2020) after an 86-day review. Its family tree reaches back 2 generations to 2019.
- Decided
- May 27, 2022
- Review
- 86 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K183287 (2019). No later device cites it as a predicate yet.
- Root · 2 generations backK183287 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2019
- 1 generation backK200181 Black Colored Powder Free Nitrile Examination Gloves Tested for Use…Comfort Rubber Gloves Industries Sdn. Bhd. · 2020
- This deviceK220609 Powder-Free Nitrile Examination Glove Tested for Use with…Encompass Industries Sdn. Bhd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2019 | — |
| −1 | K200181 | Black Colored Powder Free Nitrile Examination Gloves Tested for Use with… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020 | — |
| 0 (this device) | K220609 | Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs… | Encompass Industries Sdn. Bhd. | 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 |
|---|---|---|---|
| * | K200181 | Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy…Summary page 5…lored, Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 510(k) number : K200181 Company : Comfort Rubber Glove Industries Sdn Bhd 4. Description of Device The proposed Powder-Free Nitrile Exami… | 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 3 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 2 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. 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?
A powder-free 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. In addition, the glove was tested for chemotherapy drugs permeation. The following chemotherapy drugs have been tested with the glove: Chemotherapy Drugs Carmustine Cisplatin Cyclophosphamide Dacarbazine Doxorubicin HCL Etoposide Fluorouracil Methotrexate Paclitaxel…
Read the full statement (192 words)
A powder-free 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. In addition, the glove was tested for
chemotherapy drugs permeation.
The following chemotherapy drugs have been tested with the glove:
Chemotherapy Drugs
Carmustine
Cisplatin
Cyclophosphamide
Dacarbazine
Doxorubicin HCL
Etoposide
Fluorouracil
Methotrexate
Paclitaxel
ThioTepa
Mitomycin C
Vincristine Sulfate
Fentanyl Citrate
Concentration
3.3 mg/ml
1.0 mg/ml
20.0 mg/ml
10.0 mg/ml
2.0 mg/ml
20.0 mg/ml
50.0 mg/ml
25.0 mg/ml
6.0 mg/ml
10.0 mg/ml
0.5 mg/ml
1.0 mg/ml
100 mcg/2mL
Breakthrough Detection Time in Minutes
White
11.2
>240
>240
>240
>240
>240
>240
>240
>240
25.2
>240
>240
>240
Blue
10.7
>240
>240
>240
>240
>240
>240
>240
>240
21.5
>240
>240
>240
*Please note that the following 2 drugs have extremely low permeation times:
1. Carmustine
2. Thiotepa
Warning: Do not use with Carmustine and ThioTepa.
Black
11.0
>240
>240
>240
>240
>240
>240
>240
>240
11.1
>240
>240
>240
Orange
67.3
>240
>240
>240
>240
>240
>240
>240
>240
47.8
>240
>240
>240
Green
67.1
>240
>240
>240
>240
>240
>240
>240
>240
169.1
>240
>240
>240
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/K220609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220609: Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220609
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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