510(k) · Cleared
ClearedMedical Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Aug 20, 2021 as substantially equivalent to K180467 (Showa Best Glove, Inc., 2018) after a 252-day review. Its family tree reaches back 4 generations to 2010.
- Decided
- Aug 20, 2021
- Review
- 252 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K100603 (2010). No later device cites it as a predicate yet.
- Root · 4 generations backK100603 RS Safe Blue Nitrile Medical Examination Gloves (Powder Free)Riverstone Resources Sdn Bhd · 2010 · Recalled
- 3 generations backK112928 RS Safe White Nitrile Medical Examination Gloves Powder Free or…Riverstone Resources Sdn Bhd · 2012
- 2 generations backK141590 Emg Blue Nitrile Medical Examination Glove Powder FreeEco Medi Glove Sdn. Bhd. · 2014
- 1 generation backK180467 SBG Blue Nitrile Powder Free Medical Examination GloveShowa Best Glove, Inc. · 2018
- This deviceK203622 Medical GlovesBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K100603 | RS Safe Blue Nitrile Medical Examination Gloves (Powder Free) | Riverstone Resources Sdn Bhd | 2010 | 24 |
| −3 | K112928 | RS Safe White Nitrile Medical Examination Gloves Powder Free or Other… | Riverstone Resources Sdn Bhd | 2012 | — |
| −2 | K141590 | Emg Blue Nitrile Medical Examination Glove Powder Free | Eco Medi Glove Sdn. Bhd. | 2014 | — |
| −1 | K180467 | SBG Blue Nitrile Powder Free Medical Examination Glove | Showa Best Glove, Inc. | 2018 | — |
| 0 (this device) | K203622 | Medical Gloves | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 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 |
|---|---|---|---|
| * | K180467 | SBG Blue Nitrile Powder Free Medical Examination GloveSummary page 5…The different between each size is just in the dimension. The device can be provided in non-sterile. 5. Identification of Predicate Device 510(k) Number: K180467 Product Name: SBG Blue Nitrile Powder Free Medical Examination Glove… | 2018 |
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 11 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
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 hands or fingers to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203622: Medical Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203622
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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