510(k) · Cleared
ClearedSterile Nitrile Patient Examination Gloves, Powderfree
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sanrea Healthcare Products Pvt, Ltd. · LZA Polymer Patient Examination Glove
Cleared on Jul 19, 2017 as substantially equivalent to K132006 (Hartalega Sdn Bhd, 2013) after a 98-day review. Its family tree reaches back 1 generation to 2013. 5 later devices descend from it.
- Decided
- Jul 19, 2017
- Review
- 98 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K132006 (2013). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK132006 Sterile Nitrile Powder Free Examination Glove (Vblu), Sterle Nitrile…Hartalega Sdn Bhd · 2013
- This deviceK171093 Sterile Nitrile Patient Examination Gloves, PowderfreeSanrea Healthcare Products Pvt, Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK180452 White Nitrile Examination Glove, Sterile with Chemotherapy Drugs ClaimRiverstone Resources Sdn Bhd · 2018
- Descendant · 2 generations on · 2 of its ownK190725 Nitrile Examination Glove Sterile Tested for use with Chemotherapy…Riverstone Resources Sdn Bhd · 2019
- Descendant · 3 generations on · 1 of its ownK220250 Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for…Grand Work Plastic Products Co., Ltd. · 2022
- Descendant · 4 generations on · 0 of its ownK232039 Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for…Grand Work Plastic Products Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK212586 Amazing+Amazing Rubber Products Pvt, Ltd. · 2022
Most influential descendants
Showing 5 of 5 · See all- K180452White Nitrile Examination Glove, Sterile with Chemotherapy Drugs ClaimRiverstone Resources Sdn Bhd · 2018 · cites it directly3descendants
- K190725Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, WhiteRiverstone Resources Sdn Bhd · 2019 · 2 generations on2descendants
- K220250Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy…Grand Work Plastic Products Co., Ltd. · 2022 · 3 generations on1descendant
- K232039Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy…Grand Work Plastic Products Co., Ltd. · 2023 · 4 generations on0descendants
- K212586Amazing+Amazing Rubber Products Pvt, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K132006 | Sterile Nitrile Powder Free Examination Glove (Vblu), Sterle Nitrile Powder… | Hartalega Sdn Bhd | 2013 | — |
| 0 (this device) | K171093 | Sterile Nitrile Patient Examination Gloves, Powderfree | Sanrea Healthcare Products Pvt, Ltd. | 2017 | — |
| +1 | K180452 | White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim | Riverstone Resources Sdn Bhd | 2018 | — |
| +2 | K190725 | Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs… | Riverstone Resources Sdn Bhd | 2019 | — |
| +3 | K220250 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with… | Grand Work Plastic Products Co., Ltd. | 2022 | — |
| +4 | K232039 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with… | Grand Work Plastic Products Co., Ltd. | 2023 | — |
| +1 | K212586 | Amazing+ | Amazing Rubber Products Pvt, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K132006 | Sterile Nitrile Powder Free Examination Glove (Vblu), Sterle Nitrile Powder Free…Summary page 5…OF LEGALLY MARKETED PREDICATE DEVICE 5.1 Device Name : Sterile Nitrile Powder free Examination Glove (VBLU) 5.2 510(k) Number : K132006 5.3 Company : HARTALEGA SDN BHD, # 7, Kawasan, Perusahaan Suria,… | 2013 |
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?
- Its one ancestor has no recall.
- Of its descendants, K180452 (Riverstone Resources Sdn Bhd, 2018) has gone furthest, with 3 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. 2017, 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?
The Sterile Nitrile Patient Examination gloves, Powder free., Blue color, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171093 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171093: Sterile Nitrile Patient Examination Gloves, Powderfree.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171093
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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