510(k) · Cleared
ClearedArthrex Fingershield Finger Guard, Model AR-7199-XX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · LZB Finger Cot
Cleared on Nov 29, 2005 as substantially equivalent to K992539 (Digit-Pro, 2000) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Nov 29, 2005
- Review
- 90 days
- Class
- Class I
- Product code
- LZB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K980827 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK980827 Latex Finger Cot, Powder-Free, with Protein LabelingTucker & Associates · 1998
- This deviceK052387 Arthrex Fingershield Finger Guard, Model AR-7199-XXArthrex, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980827 | Latex Finger Cot, Powder-Free, with Protein Labeling | Tucker & Associates | 1998 | — |
| 0 (this device) | K052387 | Arthrex Fingershield Finger Guard, Model AR-7199-XX | Arthrex, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 LZB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992539 | PercuguardSummary page 1…er surgical gloves for the protection of wearer while tensioning suture or tying knots with suture products. Substantially Equivalent Product: Percuguard by Digit-Pro, K992539 Latex Finger Cot by Tucker & Associates, K980827 Substantial Equivalence: By definition, substantial equivalence means that a… | 2000 |
| * | K980827 | Latex Finger Cot, Powder-Free, with Protein LabelingSummary page 1…hile tensioning suture or tying knots with suture products. Substantially Equivalent Product: Percuguard by Digit-Pro, K992539 Latex Finger Cot by Tucker & Associates, K980827 Substantial Equivalence: By definition, substantial equivalence means that a device has the same intended use and technical ch… | 1998 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K992539.
How does its category compare?
All LZB devicesLZB Finger Cot: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZB
FDA has decided no LZB device since 2007.
Median 510(k) review, days · LZB
Too few LZB 510(k)s in any year since 2007 to give a median.
Recalls per year · LZB
No recall names LZB since 2007.
Adverse event reports per year · LZB
No MAUDE report names LZB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Arthrex Fingershield finger guards are intended to be used over surgical gloves for the protection of wearer while tensioning suture or tying knots with suture products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052387 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052387: Arthrex Fingershield Finger Guard, Model AR-7199-XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052387
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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