510(k) · Cleared
Recalled · Class II · 2021Comfit Chemo Plus Powder Free Blue Nitrile Examination Gloves, Non Sterile (Tested for Use with Chemotherapy Drug) Label
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrp Asia Pacific Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Nov 28, 2000 after a 144-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 7 times.
- Decided
- Nov 28, 2000
- Review
- 144 days
- Class
- Class I
- Product code
- LZA
- Recalls
- 7
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK002064 Comfit Chemo Plus Powder Free Blue Nitrile Examination Gloves, Non…Wrp Asia Pacific Sdn. Bhd. · 2000
- Descendant · cites it directly · 0 of its ownK083408 Powder Free Nitrile Patient Examination Gloves, Tested for Use with…Wrp Asia Pacific Sdn. Bhd. · 2009
Most influential descendants
Showing 1 of 1 · See all- K083408Powder Free Nitrile Patient Examination Gloves, Tested for Use with Chemotherapy DrugsWrp Asia Pacific Sdn. Bhd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002064 | Comfit Chemo Plus Powder Free Blue Nitrile Examination Gloves, Non Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2000 | — |
| +1 | K083408 | Powder Free Nitrile Patient Examination Gloves, Tested for Use with… | Wrp Asia Pacific Sdn. Bhd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083408 | Powder Free Nitrile Patient Examination Gloves, Tested for Use with Chemotherapy Drugs | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 7, 2021 | Class II | Z-1079-2021 | Process change control | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. |
| Jan 7, 2021 | Class II | Z-1081-2021 | Process change control | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. |
| Jan 7, 2021 | Class II | Z-1078-2021 | Process change control | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. |
| Mar 22, 2019 | Class II | Z-1286-2019 | Nonconforming Material/Component | Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap |
| Mar 22, 2019 | Class II | Z-1284-2019 | Nonconforming Material/Component | Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap |
| Mar 22, 2019 | Class II | Z-1285-2019 | Nonconforming Material/Component | Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap |
| Mar 22, 2019 | Class II | Z-1283-2019 | Nonconforming Material/Component | Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K083408 (Wrp Asia Pacific Sdn. Bhd., 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K002064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002064: Comfit Chemo Plus Powder Free Blue Nitrile Examination Gloves, Non Sterile (Tested for Use with Chemotherapy Drug) Label.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002064
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026