510(k) · Cleared
ClearedPowder Free Hyproallergenic Examination Glove (with Low Protein Claim)
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 Jan 6, 1998 after a 71-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jan 6, 1998
- Review
- 71 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK974065 Powder Free Hyproallergenic Examination Glove (with Low Protein Claim)Tillotson Healthcare Corp. · 1998
- Descendant · cites it directly · 2 of its ownK992428 Accutouch Powder Free Natural Rubber Latex Patient Examination GloveTillotson Healthcare Corp. · 1999
- Descendant · 2 generations on · 1 of its ownK013286 Cymunvera Powder Free Green Natural Rubber Latex Patient Examination…Tillotson Healthcare Corp. · 2001
- Descendant · 3 generations on · 0 of its ownK021007 Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex…Tillotson Healthcare Corp. · 2002
Most influential descendants
Showing 3 of 3 · See all- K992428Accutouch Powder Free Natural Rubber Latex Patient Examination GloveTillotson Healthcare Corp. · 1999 · cites it directly2descendants
- K013286Cymunvera Powder Free Green Natural Rubber Latex Patient Examination Glove Lined with…Tillotson Healthcare Corp. · 2001 · 2 generations on1descendant
- K021007Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex Examination Glove Made From…Tillotson Healthcare Corp. · 2002 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974065 | Powder Free Hyproallergenic Examination Glove (with Low Protein Claim) | Tillotson Healthcare Corp. | 1998 | — |
| +1 | K992428 | Accutouch Powder Free Natural Rubber Latex Patient Examination Glove | Tillotson Healthcare Corp. | 1999 | — |
| +2 | K013286 | Cymunvera Powder Free Green Natural Rubber Latex Patient Examination Glove… | Tillotson Healthcare Corp. | 2001 | — |
| +3 | 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 |
| 2001 | 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? (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 |
|---|---|---|---|
| * | — | Powder Free, Hypoallergenic Examination Glove (with low protein claim) Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992428 | Accutouch Powder Free Natural Rubber Latex Patient Examination Glove | 1999 | 2 |
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?
- Of its descendants, K992428 (Tillotson Healthcare Corp., 1999) has gone furthest, with 2 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 Powder Free, Examination Glove is "a disposable device intended
for medical purposes that is worn on the examiner's 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/K974065 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974065: Powder Free Hyproallergenic Examination Glove (with Low Protein Claim).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974065
Report an extraction error
Are you the manufacturer?
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