510(k) · Cleared
ClearedRoyal Shield Powder-Free Pineapple Scented Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shield Gloves Manufacturer (M) Sdn Bhd · LYY Latex Patient Examination Glove
Cleared on Jun 23, 1999 as substantially equivalent to K953496 (Shield Gloves Manufacturer (M) Sdn Bhd, 1995) after a 33-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jun 23, 1999
- Review
- 33 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953496 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK953496 Royal Shield Non-Sterile Powder-Free Hypoallergenic Latex…Shield Gloves Manufacturer (M) Sdn Bhd · 1995
- This deviceK991746 Royal Shield Powder-Free Pineapple Scented Latex Examination Glove…Shield Gloves Manufacturer (M) Sdn Bhd · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953496 | Royal Shield Non-Sterile Powder-Free Hypoallergenic Latex Examination Gloves | Shield Gloves Manufacturer (M) Sdn Bhd | 1995 | — |
| 0 (this device) | K991746 | Royal Shield Powder-Free Pineapple Scented Latex Examination Glove with… | Shield Gloves Manufacturer (M) Sdn Bhd | 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 |
|---|---|---|---|
| * | K953496 | Royal Shield Non-Sterile Powder-Free Hypoallergenic Latex Examination GlovesSummary page 4…ee glove. 12.0 DUSTING OR DONNING POWDER Contents for items 9.0 to 12.0 are similar to those contained in our previous submission and granted a 510(k) # K 953496 attached as APPENDIX C. : 13.0 ‘POWDER-FREE GLOVES’ APPENDIX D-1 shows the Process Flow Chart, with the addition of a scenting… | 1995 |
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?
- Its one ancestor has no 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?
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
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/K991746 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991746: Royal Shield Powder-Free Pineapple Scented Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991746
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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