510(k) · Cleared
ClearedUltra Care Non-Sterile Powder Free (Green) Natural Rubber Latex Patient Examination Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tillotson Healthcare Corp. · LYY Latex Patient Examination Glove
Cleared on Apr 2, 1999 as substantially equivalent to K960247 (Tillotson Healthcare Corp., 1996) after a 256-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Apr 2, 1999
- Review
- 256 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910383 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK910383 Hpi Sensi-Shield Glove KitHpi, Inc. · 1991
- 1 generation backK960247 Ultra Care Powder Free Hypoallergenic Patient Examination GloveTillotson Healthcare Corp. · 1996
- This deviceK982505 Ultra Care Non-Sterile Powder Free (Green) Natural Rubber Latex…Tillotson Healthcare Corp. · 1999
- Descendant · cites it directly · 0 of its ownK021007 Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex…Tillotson Healthcare Corp. · 2002
Most influential descendants
Showing 1 of 1 · See all- K021007Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex Examination Glove Made From…Tillotson Healthcare Corp. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910383 | Hpi Sensi-Shield Glove Kit | Hpi, Inc. | 1991 | — |
| −1 | K960247 | Ultra Care Powder Free Hypoallergenic Patient Examination Glove | Tillotson Healthcare Corp. | 1996 | — |
| 0 (this device) | K982505 | Ultra Care Non-Sterile Powder Free (Green) Natural Rubber Latex Patient… | Tillotson Healthcare Corp. | 1999 | — |
| +1 | K021007 | Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex Examination Glove… | Tillotson Healthcare Corp. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K960247 | Ultra Care Powder Free Hypoallergenic Patient Examination GloveSummary page 1…ASSIFICATION NAME: Examination Glove 3. PREDICATE DEVICE IDENTIFICATION Ultra Care Non-Sterile Powder Free NAME, NUMBER Natural Rubber Latex Patient Examination Glove K960247 1.Substantially Equivalent to Devices being marketed in the United States. 4. DESCRIPTION OF DEVICE a. HOW THE DEVICE FUNCTION… | 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 |
|---|---|---|---|
| K021007 | Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex Examination Glove Made From… | 2002 | 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K021007 (Tillotson Healthcare Corp., 2002) 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?
The Examination Glove is "a disposable device intended for medical purposes that is worn on the examiners 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/K982505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982505: Ultra Care Non-Sterile Powder Free (Green) Natural Rubber Latex Patient Examination Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982505
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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