510(k) · Cleared
ClearedMultiple Name
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Top Calibre Sdn Bhd · LYY Latex Patient Examination Glove
Cleared on Mar 5, 2013 as substantially equivalent to K083409 (Wrp Asia Pacific Sdn. Bhd., 2009) after an 83-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Mar 5, 2013
- Review
- 83 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972615 (1999). No later device cites it as a predicate yet.
- Root · 2 generations backK972615 Chemo Plus Powder Free Blue Latex Examination Gloves (Protein…Wembley Rubber Products (M) Sdn Bhd · 1999 · Recalled
- 1 generation backK083409 Powder Free Blue Latex Patient Examination Gloves, Tested for Use…Wrp Asia Pacific Sdn. Bhd. · 2009
- This deviceK123819 Multiple NameTop Calibre Sdn Bhd · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972615 | Chemo Plus Powder Free Blue Latex Examination Gloves (Protein Content Labeling) | Wembley Rubber Products (M) Sdn Bhd | 1999 | 3 |
| −1 | K083409 | Powder Free Blue Latex Patient Examination Gloves, Tested for Use with… | Wrp Asia Pacific Sdn. Bhd. | 2009 | — |
| 0 (this device) | K123819 | Multiple Name | Top Calibre Sdn Bhd | 2013 | — |
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 |
|---|---|---|---|
| * | K083409 | Powder Free Blue Latex Patient Examination Gloves, Tested for Use with Chemotherapy…Summary page 1…LYY, Specialty - 80 LZC, meets all of the requirements of ASTM D3578-05 (2010) Standard Specification for. Rubber Examination Glove. Predicate Device: K083409, Powder Free Blue Latex Patient Examination Glove, Tested for use with Chemotherapy Drugs with a Protein Content Label Clai… | 2009 |
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 14 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K083409.
How does its category compare?
All LYY devicesLYY Latex Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
A 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. This glove has been tested for use with specific chemotherapy drugs listed below. Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes) Carmustine (BCNU) (3.3 mg/ml) 15.4 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (Cytoxan) (20.0 mg/ml) >240 Cytarabine (100…
Read the full statement (136 words)
A 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.
This glove has been tested for use with specific chemotherapy drugs listed below.
Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes)
Carmustine (BCNU) (3.3 mg/ml) 15.4
Cisplatin (1.0 mg/ml) >240
Cyclophosphamide (Cytoxan) (20.0 mg/ml) >240
Cytarabine (100 mg/ml) >240
Dacarbazine (DTIC) (10.0 mg/ml) >240
Doxorubicin Hydrochloride (2.0 mg/ml) >240
Etoposide (20.0 mg/ml) >240
Fluorouracil (50.0 mg/ml) >240
Ifosfamide (50.0 mg/ml) >240
Methotrexate (25 mg/ml) >240
Mitomycin C (0.5 mg/ml) >240
Mitoxantrone (2.0 mg/ml) >240
Paclitaxel (Taxol) (6.0 mg/ml) >240
Thiotepa (10.0 mg/ml) 30.6
Vincristine Sulfate (1.0 mg/ml) >240
Please note that the following drugs - Carmustine and Thiotepa have extremely short permeation times of 15.4 and 30.6 minutes, respectively.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123819: Multiple Name.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123819
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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