510(k) · Cleared
ClearedLatex Examination Glove Powder Free
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Careglove Global Sdn. Bhd. · LYY Latex Patient Examination Glove
Cleared on May 23, 2017 as substantially equivalent to K152593 (Careplus (M) Sdn Bhd, 2016) after a 322-day review. Its family tree reaches back 1 generation to 2016. 6 later devices descend from it.
- Decided
- May 23, 2017
- Review
- 322 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K152593 (2016). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK152593 Latex Examination Glove Powder FreeCareplus (M) Sdn Bhd · 2016
- This deviceK161833 Latex Examination Glove Powder FreeCareglove Global Sdn. Bhd. · 2017
- Descendant · cites it directly · 3 of its ownK173053 Powder Free Latex Examination GloveProfessional Latex Sdn Bhd · 2018
- Descendant · 2 generations on · 2 of its ownK214017 Examination gloves-Type A (Latex gloves)Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK222612 Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK222693 Single-use medical latex examination gloves (LG100)Fitone Latex Products Co., Ltd. Guangdong · 2022
- Descendant · cites it directly · 0 of its ownK221648 Iconic Latex GloveIconic Medicare Sdn Bhd · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K173053Powder Free Latex Examination GloveProfessional Latex Sdn Bhd · 2018 · cites it directly3descendants
- K214017Examination gloves-Type A (Latex gloves)Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · 2022 · 2 generations on2descendants
- K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2022 · 3 generations on0descendants
- K222693Single-use medical latex examination gloves (LG100)Fitone Latex Products Co., Ltd. Guangdong · 2022 · 3 generations on0descendants
- K221648Iconic Latex GloveIconic Medicare Sdn Bhd · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K152593 | Latex Examination Glove Powder Free | Careplus (M) Sdn Bhd | 2016 | — |
| 0 (this device) | K161833 | Latex Examination Glove Powder Free | Careglove Global Sdn. Bhd. | 2017 | — |
| +1 | K173053 | Powder Free Latex Examination Glove | Professional Latex Sdn Bhd | 2018 | — |
| +2 | K214017 | Examination gloves-Type A (Latex gloves) | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | 2022 | — |
| +3 | K222612 | Powder-Free Latex examination gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022 | — |
| +3 | K222693 | Single-use medical latex examination gloves (LG100) | Fitone Latex Products Co., Ltd. Guangdong | 2022 | — |
| +1 | K221648 | Iconic Latex Glove | Iconic Medicare Sdn Bhd | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 5 | 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 |
|---|---|---|---|
| * | K152593 | Latex Examination Glove Powder FreeSummary page 5…Specifications References Values, K161833 Device, K152593 Value Status Dimension Length… | 2016 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All LYY devicesLYY Latex Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 or
finger 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/K161833 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161833: Latex Examination Glove Powder Free.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161833
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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