510(k) · Cleared
ClearedDuraclean with Lycra Powder Free Polyurethane Medical Examination Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilshire Technologies · LZA Polymer Patient Examination Glove
Cleared on Aug 9, 2002 as substantially equivalent to K991615 (Maxxim Medical, 1999) and 7 other predicates after a 43-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Aug 9, 2002
- Review
- 43 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 2 generations to K905109 (1990). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK905109 Patient Examination Glove/HypoallergenicTactyl Technologies, Inc. · 1990
- 1 generation backK955464 Tactylon Powder Free Examination GloveTactyl Technologies, Inc. · 1996
- This deviceK022095 Duraclean with Lycra Powder Free Polyurethane Medical Examination…Wilshire Technologies · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905109 | Patient Examination Glove/Hypoallergenic | Tactyl Technologies, Inc. | 1990 | — |
| −1 | K955464 | Tactylon Powder Free Examination Glove | Tactyl Technologies, Inc. | 1996 | — |
| 0 (this device) | K022095 | Duraclean with Lycra Powder Free Polyurethane Medical Examination Glove | Wilshire Technologies | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 4 | 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 LZA? 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 LZA device
- #1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 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? (8)
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 |
|---|---|---|---|
| * | K991615 | Polyurethane Powder Free Dental Examination Glove, Polyurethane Powder Free Medical…Summary page 1…C. Predicate Devices The subject device is substantially equivalent, in whole or in part, to predicate gloves manufactured by Maxxim Medical (K991615, KO10297 and KO1 1198), Wilshire Technologies (K950033), WRP Asia Pacific (KO1 1482 and KO12048), SGMP (K… | 1999 |
| * | K010297 | Sensicare Synthetic Powder Free Surgical Gloves (Poly Isoprene) | 2001 |
| * | K011198 | Senicare Advantix Powder Free Polyurethane Medical Examination Glove, Sensicare Advantix… | 2001 |
| * | K950033 | PolydermSummary page 1…ially equivalent, in whole or in part, to predicate gloves manufactured by Maxxim Medical (K991615, KO10297 and KO1 1198), Wilshire Technologies (K950033), WRP Asia Pacific (KO1 1482 and KO12048), SGMP (KO203 17), and Tactyl Technologies (K955464). D. Device Desc… | 1995 |
| * | K011482 | Dermasafe Chemo Plus Powder Free Neoprene Examination Glove (Tested for Use with… | 2001 |
| * | K012048 | Powder Free Neoprene Examination Gloves, Non Sterile | 2001 |
| * | K020317 | Non-Sterile Powder Free Green Barrier-Pro Synthetic Butadiene Copolymer Examination… | 2002 |
| * | K955464 | Tactylon Powder Free Examination GloveSummary page 1…91615, KO10297 and KO1 1198), Wilshire Technologies (K950033), WRP Asia Pacific (KO1 1482 and KO12048), SGMP (KO203 17), and Tactyl Technologies (K955464). D. Device Description The subject device is an ambidextrous, powder-free patient examination glove… | 1996 |
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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
- None of the 11 ancestors has a recall.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZA
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZA
110in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZA
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZA
73in 2025
MAUDE reports naming product code LZA, 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 | 21 | 95 | 0 | 7 |
| 2008 | 18 | 97 | 0 | 2 |
| 2009 | 28 | 112 | 0 | 12 |
| 2010 | 31 | 97 | 0 | 12 |
| 2011 | 26 | 122 | 0 | 9 |
| 2012 | 33 | 110 | 0 | 11 |
| 2013 | 20 | 130 | 0 | 10 |
| 2014 | 27 | 197 | 0 | 8 |
| 2015 | 20 | 112 | 1 | 12 |
| 2016 | 30 | 171 | 1 | 25 |
| 2017 | 44 | 124 | 0 | 4 |
| 2018 | 22 | 178 | 0 | 3 |
| 2019 | 25 | 212 | 0 | 21 |
| 2020 | 30 | 101 | 0 | 4 |
| 2021 | 139 | 111 | 0 | 20 |
| 2022 | 146 | 111 | 0 | 19 |
| 2023 | 62 | 92 | 0 | 24 |
| 2024 | 30 | 89 | 0 | 76 |
| 2025 | 24 | 110 | 0 | 73 |
| 2026 | 15 | 103 | 3 | — |
What is it indicated for?
DuraCLEANB with LYCRA @ Medical Examination Glove is a disposable device made of synthetic LYCRAB polymer that is intended for medical purposes to be worn on the examiner's hand to provide a barrier against potentially infectious materials and other contaminants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022095: Duraclean with Lycra Powder Free Polyurethane Medical 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/K022095
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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