510(k) · Cleared
ClearedLatex Exam Glove, Powder-Free W/Protein & Hypoallergenic Labeling
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evergrade Healthcare Products Sdn Bhd · LYY Latex Patient Examination Glove
Cleared on Mar 13, 1998 as substantially equivalent to K955918 (Sinochem Ningbo Imp & Exp Corp., 1996) after a 169-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Mar 13, 1998
- Review
- 169 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955918 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK955918 Sinochem Ningbo Latex Examination Glove, Powder FreeSinochem Ningbo Imp & Exp Corp. · 1996
- This deviceK973664 Latex Exam Glove, Powder-Free W/Protein & Hypoallergenic LabelingEvergrade Healthcare Products Sdn Bhd · 1998
- Descendant · cites it directly · 0 of its ownK992031 Latex Examination Glove Powder Free, with Protein Labeling Claim (50…Shanghai Changzheng Latex Factory · 1999
Most influential descendants
Showing 1 of 1 · See all- K992031Latex Examination Glove Powder Free, with Protein Labeling Claim (50 Micrograms or Less…Shanghai Changzheng Latex Factory · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955918 | Sinochem Ningbo Latex Examination Glove, Powder Free | Sinochem Ningbo Imp & Exp Corp. | 1996 | — |
| 0 (this device) | K973664 | Latex Exam Glove, Powder-Free W/Protein & Hypoallergenic Labeling | Evergrade Healthcare Products Sdn Bhd | 1998 | — |
| +1 | K992031 | Latex Examination Glove Powder Free, with Protein Labeling Claim (50… | Shanghai Changzheng Latex Factory | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 |
|---|---|---|---|
| * | K955918 | Sinochem Ningbo Latex Examination Glove, Powder FreeSummary page 1…aracteristics, this device is equivalent to devices currently marketed by U.S. companies. It is Substantially E quivalent to the device manufactured by Sinochem Ningbo, K955918, Latex Exam Gloves, powder-free, with Protein Labeling and Hypoallergenic Claims. EXH/BEIT H ngfiwé‘f a1 Test Res… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992031 | Latex Examination Glove Powder Free, with Protein Labeling Claim (50 Micrograms or Less… | 1999 | 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, K992031 (Shanghai Changzheng Latex Factory, 1999) has gone furthest, with 0 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?
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/K973664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973664: Latex Exam Glove, Powder-Free W/Protein & Hypoallergenic Labeling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973664
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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