510(k) · Cleared
ClearedUltra Care Powder Free Hypoallergenic 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 Jul 29, 1996 as substantially equivalent to K910383 (Hpi, Inc., 1991) after a 195-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- Jul 29, 1996
- Review
- 195 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K910383 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK910383 Hpi Sensi-Shield Glove KitHpi, Inc. · 1991
- This deviceK960247 Ultra Care Powder Free Hypoallergenic Patient Examination GloveTillotson Healthcare Corp. · 1996
- Descendant · cites it directly · 1 of its ownK982505 Ultra Care Non-Sterile Powder Free (Green) Natural Rubber Latex…Tillotson Healthcare Corp. · 1999
- Descendant · 2 generations on · 0 of its ownK021007 Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex…Tillotson Healthcare Corp. · 2002
Most influential descendants
Showing 2 of 2 · See all- K982505Ultra Care Non-Sterile Powder Free (Green) Natural Rubber Latex Patient Examination GloveTillotson Healthcare Corp. · 1999 · cites it directly1descendant
- K021007Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex Examination Glove Made From…Tillotson Healthcare Corp. · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910383 | Hpi Sensi-Shield Glove Kit | Hpi, Inc. | 1991 | — |
| 0 (this device) | K960247 | Ultra Care Powder Free Hypoallergenic Patient Examination Glove | Tillotson Healthcare Corp. | 1996 | — |
| +1 | K982505 | Ultra Care Non-Sterile Powder Free (Green) Natural Rubber Latex Patient… | Tillotson Healthcare Corp. | 1999 | — |
| +2 | 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 |
|---|---|---|
| 1999 | 1 | 0 |
| 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K891936 | FDA’s K891936 is Patient Examination Gloves (Latex) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1989 |
| * | K910383 | Hpi Sensi-Shield Glove KitSummary page 1…terile Powder Free Patient Examination Glove Hypoallergenic Patient Examination Glove 1. Formuia One Patient Exam Glove K89193% 2. Sensi Shield Glove Kit, innar Glove, K910383 {Hypoallergenic) Patient examination gioves are made with an intact natural {atex rubber film, which provides a barrier to body… | 1991 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982505 | Ultra Care Non-Sterile Powder Free (Green) Natural Rubber Latex Patient Examination Glove | 1999 | 1 |
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.
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 disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner.
Hypoallergenic patient examination gloves are suitable in situations where healthcare worker or patient allergic sensitivity may be a factor.
Powder free gloves are intended for use in situations where powder should not be used.
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/K960247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960247: Ultra Care Powder Free Hypoallergenic 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/K960247
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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