510(k) · Cleared
ClearedNon-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Semperit Investments Asia Pte, Ltd. · LZA Polymer Patient Examination Glove
Cleared on Sep 14, 2017 as substantially equivalent to K083755 (Siam Sempermed Corp., Ltd., 2009) after a 127-day review. Its family tree reaches back 4 generations to 2000. 3 later devices descend from it.
- Decided
- Sep 14, 2017
- Review
- 127 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000323 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK000323 Nitrile Patient Examination Glove (Blue Color) Powder Free, Non…Siam Sempermed Corp., Ltd. · 2000
- 3 generations backK060753 Non-Sterile, Powder Free Nitrile Examination Glove, Blue with…Siam Sempermed Corp., Ltd. · 2006
- 2 generations backK080520 Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer…Siam Sempermed Corp., Ltd. · 2008
- 1 generation backK083755 Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue…Siam Sempermed Corp., Ltd. · 2009
- This deviceK171378 Non-Sterile, Single use, Powder-free examination glove tested for…Semperit Investments Asia Pte, Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK223903 Non-Sterile, Single use, Powder-free examination glove, Blue, tested…Semperit Investments Asia Pte, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK233990 Nitrile Disposable Examination Gloves, Tested for Use with…Shandong Xingyu Gloves Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK233520 Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested…Anhui Powerguard Technology Co., Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See all- K223903Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with…Semperit Investments Asia Pte, Ltd. · 2023 · cites it directly2descendants
- K233990Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and…Shandong Xingyu Gloves Co., Ltd. · 2024 · 2 generations on0descendants
- K233520Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with…Anhui Powerguard Technology Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000323 | Nitrile Patient Examination Glove (Blue Color) Powder Free, Non Sterile | Siam Sempermed Corp., Ltd. | 2000 | — |
| −3 | K060753 | Non-Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating… | Siam Sempermed Corp., Ltd. | 2006 | — |
| −2 | K080520 | Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with… | Siam Sempermed Corp., Ltd. | 2008 | — |
| −1 | K083755 | Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color… | Siam Sempermed Corp., Ltd. | 2009 | — |
| 0 (this device) | K171378 | Non-Sterile, Single use, Powder-free examination glove tested for use with… | Semperit Investments Asia Pte, Ltd. | 2017 | — |
| +1 | K223903 | Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use… | Semperit Investments Asia Pte, Ltd. | 2023 | — |
| +2 | K233990 | Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs… | Shandong Xingyu Gloves Co., Ltd. | 2024 | — |
| +2 | K233520 | Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with… | Anhui Powerguard Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K083755 | Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color, Polymer Coated…Summary page 4…tial equivalency is claimed against the following predicate device(s): 510k number Trade or Proprietary or Model Name Manufacturer K083755 Non-Sterile, Powder-free Nitrile Examination glove, Siam Sempermed Corp, Ltd Lavender blue w… | 2009 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223903 | Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with… | 2023 | 2 |
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 17 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K223903 (Semperit Investments Asia Pte, Ltd., 2023) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K083755.
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?
This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are: Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes. Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240…
Read the full statement (225 words)
This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are:
Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes.
Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Cyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Cytarabine (100 mg/ml). Permeation time: no breakthrough up to 240 minutes
Dacarbazine (DTIC) (10.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Doxorubicin Hydrochloride (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Etoposide (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Fluorouracil (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Ifosfamide (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Methotrexate (25.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Mitomycin C (0.5 mg/ml). Permeation time: no breakthrough up to 240 minutes
Mitoxantrone (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Paclitaxel (Taxol) (6.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Thiotepa (10.0 mg/ml). Permeation time: Thiotepa has extremely low permeation times of 13.6 minutes
Vincristine Sulfate (1.0 mg/ml). Permeation time: no Breakthrough up to 240 minutes
DO NOT USE WITH CARMUSTINE OR THIOTEPA
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171378: Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171378
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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