510(k) · Cleared
ClearedNitrile Examination Gloves-Pre Powdered
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Influx Pacific Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Sep 26, 1997 after a 253-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Sep 26, 1997
- Review
- 253 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK970216 Nitrile Examination Gloves-Pre PowderedInflux Pacific Sdn. Bhd. · 1997
- Descendant · cites it directly · 2 of its ownK974710 Nitrile Exam Glove, Powder-Free/White and BlueSinochem Ningbo Latex Gloves Factory · 1998
- Descendant · 2 generations on · 1 of its ownK980802 Nitrile Exam Glove, Powder-Free, BlueTucker & Associates · 1998
- Descendant · cites it directly · 1 of its ownK980677 Nitrile Exam Glove, Powder FreeNingbo Yujiang Plastic & Rubber Co., Ltd. · 1998
- Descendant · 3 generations on · 0 of its ownK013998 Powder-Free Lavender/Purple Nitrile Exam GlovesSheen More Ent. Co., Ltd. · 2002
- Descendant · 2 generations on · 0 of its ownK991821 Nitrile Examination Glove, Powdered, BlueNing BO Yujiang Rubber & Plastic Co. · 1999
Most influential descendants
Showing 5 of 5 · See all- K974710Nitrile Exam Glove, Powder-Free/White and BlueSinochem Ningbo Latex Gloves Factory · 1998 · cites it directly2descendants
- K980802Nitrile Exam Glove, Powder-Free, BlueTucker & Associates · 1998 · 2 generations on1descendant
- K980677Nitrile Exam Glove, Powder FreeNingbo Yujiang Plastic & Rubber Co., Ltd. · 1998 · cites it directly1descendant
- K013998Powder-Free Lavender/Purple Nitrile Exam GlovesSheen More Ent. Co., Ltd. · 2002 · 3 generations on0descendants
- K991821Nitrile Examination Glove, Powdered, BlueNing BO Yujiang Rubber & Plastic Co. · 1999 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970216 | Nitrile Examination Gloves-Pre Powdered | Influx Pacific Sdn. Bhd. | 1997 | — |
| +1 | K974710 | Nitrile Exam Glove, Powder-Free/White and Blue | Sinochem Ningbo Latex Gloves Factory | 1998 | — |
| +2 | K980802 | Nitrile Exam Glove, Powder-Free, Blue | Tucker & Associates | 1998 | — |
| +1 | K980677 | Nitrile Exam Glove, Powder Free | Ningbo Yujiang Plastic & Rubber Co., Ltd. | 1998 | — |
| +3 | K013998 | Powder-Free Lavender/Purple Nitrile Exam Gloves | Sheen More Ent. Co., Ltd. | 2002 | — |
| +2 | K991821 | Nitrile Examination Glove, Powdered, Blue | Ning BO Yujiang Rubber & Plastic Co. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
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?
- Of its descendants, K974710 (Sinochem Ningbo Latex Gloves Factory, 1998) has gone furthest, with 2 descendants 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.
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 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 read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970216 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970216: Nitrile Examination Gloves-Pre Powdered.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970216
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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