510(k) · Cleared
ClearedBlue Latex Examination Powder Free Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jr Engineering & Medical Technologies (M) Sdn. Bhd. · LYY Latex Patient Examination Glove
Cleared on Nov 25, 2019 as substantially equivalent to K141042 (Mercator Medical (Thailand), Ltd., 2015) after a 90-day review. Its family tree reaches back 1 generation to 2015. 10 later devices descend from it.
- Decided
- Nov 25, 2019
- Review
- 90 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K141042 (2015). 10 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK141042 Mcare PF Powder Free Latex Examination High Risk GlovesMercator Medical (Thailand), Ltd. · 2015
- This deviceK192329 Blue Latex Examination Powder Free GlovesJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2019
- Descendant · cites it directly · 4 of its ownK202377 Palm Care Latex Examination Powder Free GlovesHi-Care Thai Gloves Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK250069 Powder Free Natural Rubber Latex Examination Gloves – Blue…Comfort Rubber Gloves Industries Sdn. Bhd. · 2025
- Descendant · cites it directly · 0 of its ownK222348 JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2022
- Descendant · 2 generations on · 0 of its ownK211601 Powder Free Latex Examination Glove, Non-SterileWrp Asia Pacific Sdn. Bhd. · 2022
- Descendant · 2 generations on · 0 of its ownK221185 TC GlovesThanh Cong Pharmaceutical and Trading Company Limited · 2022
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K202377Palm Care Latex Examination Powder Free GlovesHi-Care Thai Gloves Co., Ltd. · 2020 · cites it directly4descendants
- K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein…Comfort Rubber Gloves Industries Sdn. Bhd. · 2025 · cites it directly0descendants
- K222348JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2022 · cites it directly0descendants
- K211601Powder Free Latex Examination Glove, Non-SterileWrp Asia Pacific Sdn. Bhd. · 2022 · 2 generations on0descendants
- K221185TC GlovesThanh Cong Pharmaceutical and Trading Company Limited · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K141042 | Mcare PF Powder Free Latex Examination High Risk Gloves | Mercator Medical (Thailand), Ltd. | 2015 | — |
| 0 (this device) | K192329 | Blue Latex Examination Powder Free Gloves | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2019 | — |
| +1 | K202377 | Palm Care Latex Examination Powder Free Gloves | Hi-Care Thai Gloves Co., Ltd. | 2020 | — |
| +1 | K250069 | Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2025 | — |
| +1 | K222348 | JR Medic | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2022 | — |
| +2 | K211601 | Powder Free Latex Examination Glove, Non-Sterile | Wrp Asia Pacific Sdn. Bhd. | 2022 | — |
| +2 | K221185 | TC Gloves | Thanh Cong Pharmaceutical and Trading Company Limited | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K141042 | Mcare PF Powder Free Latex Examination High Risk GlovesSummary page 4…neral Hospital C. PREDICATE DEVICE Legally Marketed devices that MCARE PF Powder-free Latex Examination Gloves Equivalency is claimed 510 (K) Number K141042 Regulatory Class Class I Product code LYY D. DESCRIPTION OF THE DEVICE: Blue Latex Examinatio… | 2015 |
What descends from it? (10)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202377 | Palm Care Latex Examination Powder Free Gloves | 2020 | 4 |
| K250069 | Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein… | 2025 | 0 |
| K222348 | JR Medic | 2022 | 0 |
| K212597 | Amazing+ Latex Examination Powder Free Gloves | 2022 | 0 |
| K213775 | Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves | 2022 | 0 |
| K211477 | Latex Examination Powder Free Gloves | 2021 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K202377 (Hi-Care Thai Gloves Co., Ltd., 2020) has gone furthest, with 4 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. 2019, 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?
Blue Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are worn on the examiner’s hand to prevent contamination between patient and examiner.
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/K192329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192329: Blue Latex Examination Powder Free Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192329
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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