510(k) · Cleared
ClearedProclean - Nitrile Powder Free Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dr.Boo Company Limited · LZA Polymer Patient Examination Glove
Cleared on Oct 13, 2021 as substantially equivalent to K202384 (Hi-Care Thai Gloves Co., Ltd., 2020) after a 162-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Oct 13, 2021
- Review
- 162 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K022548 (2002). No later device cites it as a predicate yet.
- Root · 4 generations backK022548 Medtexx Blue Colour Powder-Free Nitrile Rubber Examination GlovesLatexx Manufacturing Sdn.Bhd. · 2002
- 3 generations backK172930 mCare Powder-free Blue Nitrile Examination GlovesMercator Medical (Thailand), Ltd. · 2018
- 2 generations backK192333 Blue Nitrile Examination Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2020
- 1 generation backK202384 Palm Care Blue Nitrile Examination Gloves Powder FreeHi-Care Thai Gloves Co., Ltd. · 2020
- This deviceK211374 Proclean - Nitrile Powder Free Examination GlovesDr.Boo Company Limited · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K022548 | Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves | Latexx Manufacturing Sdn.Bhd. | 2002 | — |
| −3 | K172930 | mCare Powder-free Blue Nitrile Examination Gloves | Mercator Medical (Thailand), Ltd. | 2018 | — |
| −2 | K192333 | Blue Nitrile Examination Gloves Powder Free | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2020 | — |
| −1 | K202384 | Palm Care Blue Nitrile Examination Gloves Powder Free | Hi-Care Thai Gloves Co., Ltd. | 2020 | — |
| 0 (this device) | K211374 | Proclean - Nitrile Powder Free Examination Gloves | Dr.Boo Company Limited | 2021 | — |
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? (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 |
|---|---|---|---|
| * | K202384 | Palm Care Blue Nitrile Examination Gloves Powder FreeSummary page 4…al Hospital 3.0 Predicate Device Device Name: Palm Care Blue Nitrile Examination Gloves Powder Free 510(k): K202384 Common Name: Patient Examination Gloves Classification Name: Patient Examination… | 2020 |
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 19 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
- 7 other devices also cite its predicate K202384.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
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?
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211374 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211374: Proclean - Nitrile Powder Free Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211374
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