510(k) · Cleared
ClearedC2 Medical Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amercare, Inc. · LZA Polymer Patient Examination Glove
Cleared on May 8, 2012 as substantially equivalent to K110944 (Wangda Plastic Co., Ltd., 2011) after a 151-day review. Its family tree reaches back 3 generations to 2000. 3 later devices descend from it.
- Decided
- May 8, 2012
- Review
- 151 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000071 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK000071 Synthetic Powder Free (White) Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 2000
- 2 generations backK032908 Fuguan (Brand) Powder-Free Vinyl Patient Examination GlovesShijiazhuang Fuguan Plastic Products Co., Ltd. · 2003
- 1 generation backK110944 Powder-Free Vinyl Patient Examination GlovesWangda Plastic Co., Ltd. · 2011
- This deviceK113639 C2 Medical GlovesAmercare, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK173228 U-MED Powder Free Polyethylene Examination Gloves,Blue ColorJiangsu U-Med Rubber & Plastic Products Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK212699 Disposable Powder Free Polyethylene Examination GlovesMastermax Plastic (Huizhou), Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK133478 Powder Free Polyethylene Examination GlovesShijiazhuang Hongzan Plastic Technology Co.,Ltd · 2014
Most influential descendants
Showing 3 of 3 · See all- K173228U-MED Powder Free Polyethylene Examination Gloves,Blue ColorJiangsu U-Med Rubber & Plastic Products Co., Ltd. · 2018 · cites it directly1descendant
- K212699Disposable Powder Free Polyethylene Examination GlovesMastermax Plastic (Huizhou), Ltd. · 2022 · 2 generations on0descendants
- K133478Powder Free Polyethylene Examination GlovesShijiazhuang Hongzan Plastic Technology Co.,Ltd · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000071 | Synthetic Powder Free (White) Vinyl Patient Examination Gloves | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 2000 | — |
| −2 | K032908 | Fuguan (Brand) Powder-Free Vinyl Patient Examination Gloves | Shijiazhuang Fuguan Plastic Products Co., Ltd. | 2003 | — |
| −1 | K110944 | Powder-Free Vinyl Patient Examination Gloves | Wangda Plastic Co., Ltd. | 2011 | — |
| 0 (this device) | K113639 | C2 Medical Gloves | Amercare, Inc. | 2012 | — |
| +1 | K173228 | U-MED Powder Free Polyethylene Examination Gloves,Blue Color | Jiangsu U-Med Rubber & Plastic Products Co., Ltd. | 2018 | — |
| +2 | K212699 | Disposable Powder Free Polyethylene Examination Gloves | Mastermax Plastic (Huizhou), Ltd. | 2022 | — |
| +1 | K133478 | Powder Free Polyethylene Examination Gloves | Shijiazhuang Hongzan Plastic Technology Co.,Ltd | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K110944 | Powder-Free Vinyl Patient Examination GlovesSummary page 1…ent Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital Product Code: LZA Device Class: 1 Predicate Device K110944 Non-sterile Powder Free Vinyl Patient Examination Gloves Clear (non)colored… | 2011 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K173228 (Jiangsu U-Med Rubber & Plastic Products Co., Ltd., 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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, non-sterile patient examination glove is a disposable device intended for medical purposes to be 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/K113639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113639: C2 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/K113639
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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