510(k) · Cleared
ClearedLatex Examination Glove Powder Free, with Protein Labeling Claim (50 Micrograms or Less Total Water Soluble Protein)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Changzheng Latex Factory · LYY Latex Patient Examination Glove
Cleared on Jul 12, 1999 as substantially equivalent to K973664 (Evergrade Healthcare Products Sdn Bhd, 1998) after a 26-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Jul 12, 1999
- Review
- 26 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955918 (1996). No later device cites it as a predicate yet.
- Root · 2 generations backK955918 Sinochem Ningbo Latex Examination Glove, Powder FreeSinochem Ningbo Imp & Exp Corp. · 1996
- 1 generation backK973664 Latex Exam Glove, Powder-Free W/Protein & Hypoallergenic LabelingEvergrade Healthcare Products Sdn Bhd · 1998
- This deviceK992031 Latex Examination Glove Powder Free, with Protein Labeling Claim (50…Shanghai Changzheng Latex Factory · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955918 | Sinochem Ningbo Latex Examination Glove, Powder Free | Sinochem Ningbo Imp & Exp Corp. | 1996 | — |
| −1 | K973664 | Latex Exam Glove, Powder-Free W/Protein & Hypoallergenic Labeling | Evergrade Healthcare Products Sdn Bhd | 1998 | — |
| 0 (this device) | K992031 | Latex Examination Glove Powder Free, with Protein Labeling Claim (50… | Shanghai Changzheng Latex Factory | 1999 | — |
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 |
|---|---|---|---|
| * | K973664 | Latex Exam Glove, Powder-Free W/Protein & Hypoallergenic LabelingSummary page 1…vice is equivalent to devices currently marketed by U.S. companies. It is substantially equivalent to the device manufactured by Evergrade Healthcare Products SDN BHD, K973664, Latex Examination Glove, Powder-Free, with Protein Content Labeling Claim. Test Results (Means and/or Results):… | 1998 |
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 3 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 2 ancestors has a recall.
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?
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/K992031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992031: Latex Examination Glove Powder Free, with Protein Labeling Claim (50 Micrograms or Less Total Water Soluble Protein).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992031
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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