510(k) · Cleared
Recalled · Class II · 2021Chemo Plus Powder Free Blue Latex Examination Gloves (Protein Content Labeling)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wembley Rubber Products (M) Sdn Bhd · LYY Latex Patient Examination Glove
Cleared on Jan 26, 1999 after a 561-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 26, 1999
- Review
- 561 days
- Class
- Class I
- Product code
- LYY
- Recalls
- 3
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK972615 Chemo Plus Powder Free Blue Latex Examination Gloves (Protein…Wembley Rubber Products (M) Sdn Bhd · 1999
- Descendant · cites it directly · 3 of its ownK083409 Powder Free Blue Latex Patient Examination Gloves, Tested for Use…Wrp Asia Pacific Sdn. Bhd. · 2009
- Descendant · 2 generations on · 1 of its ownK121926 Blue, Latex Powder Free Examination Gloves, Tested for Use with…Northstar Healthcare Holdings · 2012
- Descendant · 3 generations on · 0 of its ownK221157 JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2022
- Descendant · 2 generations on · 0 of its ownK123819 Multiple NameTop Calibre Sdn Bhd · 2013
Most influential descendants
Showing 4 of 4 · See all- K083409Powder Free Blue Latex Patient Examination Gloves, Tested for Use with Chemotherapy…Wrp Asia Pacific Sdn. Bhd. · 2009 · cites it directly3descendants
- K121926Blue, Latex Powder Free Examination Gloves, Tested for Use with Chemotherapy Drugs with…Northstar Healthcare Holdings · 2012 · 2 generations on1descendant
- K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2022 · 3 generations on0descendants
- K123819Multiple NameTop Calibre Sdn Bhd · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972615 | Chemo Plus Powder Free Blue Latex Examination Gloves (Protein Content Labeling) | Wembley Rubber Products (M) Sdn Bhd | 1999 | — |
| +1 | K083409 | Powder Free Blue Latex Patient Examination Gloves, Tested for Use with… | Wrp Asia Pacific Sdn. Bhd. | 2009 | — |
| +2 | K121926 | Blue, Latex Powder Free Examination Gloves, Tested for Use with Chemotherapy… | Northstar Healthcare Holdings | 2012 | — |
| +3 | K221157 | JR Medic | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2022 | — |
| +2 | K123819 | Multiple Name | Top Calibre Sdn Bhd | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2022 | 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 LYY? 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 LYY device
- #1 K202377 Palm Care Latex Examination Powder Free Glovesscore 12.7 · 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 |
|---|---|---|---|
| * | — | Class I latex patient examination glove 80 LZC, powder free, protein content labeling… Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083409 | Powder Free Blue Latex Patient Examination Gloves, Tested for Use with Chemotherapy… | 2009 | 3 |
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-1080-2021 | 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-1082-2021 | 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-1083-2021 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K083409 (Wrp Asia Pacific Sdn. Bhd., 2009) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LYY devicesLYY Latex Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYY
150in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYY
1in 2025
MAUDE reports naming product code LYY, 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 | 12 | 75 | 0 | 11 |
| 2008 | 13 | 151 | 0 | 14 |
| 2009 | 7 | 76 | 0 | 11 |
| 2010 | 13 | 106 | 0 | 10 |
| 2011 | 11 | 127 | 1 | 4 |
| 2012 | 11 | 133 | 0 | 1 |
| 2013 | 6 | 131 | 0 | 2 |
| 2014 | 3 | 156 | 0 | 6 |
| 2015 | 3 | 251 | 0 | 5 |
| 2016 | 4 | 142 | 0 | 7 |
| 2017 | 4 | 230 | 0 | 7 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 7 |
| 2020 | 1 | — | 1 | 1 |
| 2021 | 8 | 188 | 0 | 1 |
| 2022 | 14 | 150 | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between examiner and chemotherapy agents.
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/K972615 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972615: Chemo Plus Powder Free Blue Latex Examination Gloves (Protein Content Labeling).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972615
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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