510(k) · Cleared
ClearedNitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Basic Medical Technology, Inc. · LZA Polymer Patient Examination Glove
Cleared on Aug 27, 2025 as substantially equivalent to K212408 (Pt. Maja Agung Latexindo, 2022) after an 84-day review. Its family tree reaches back 6 generations to 2004.
- Decided
- Aug 27, 2025
- Review
- 84 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K042805 (2004). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 5 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 4 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 3 generations backK161187 EMG Blue Nitrile Examination Gloves Powder Free with Tested for use…Eco Medi Glove Sdn. Bhd. · 2016
- 2 generations backK171339 EMG Blue Nitrile Examination Gloves Powder free with tested for use…Eco Medi Glove Sdn. Bhd. · 2017
- 1 generation backK212408 Powder Free Nitrile Examination Gloves (Tested for Use with…Pt. Maja Agung Latexindo · 2022
- This deviceK251716 Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy…Basic Medical Technology, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −5 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −4 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −3 | K161187 | EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with… | Eco Medi Glove Sdn. Bhd. | 2016 | — |
| −2 | K171339 | EMG Blue Nitrile Examination Gloves Powder free with tested for use with… | Eco Medi Glove Sdn. Bhd. | 2017 | — |
| −1 | K212408 | Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs… | Pt. Maja Agung Latexindo | 2022 | — |
| 0 (this device) | K251716 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid… | Basic Medical Technology, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K212408 | Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and…Summary page 6…on Panel: General Hospital Device Class: Class I 4. Predicate Device Information Primary Predicate Device: Applicant: Pt. Maja Agung Latexindo 510(k) #: K212408 Trade Name: Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs, Simulated Gastric Acid, and… | 2022 |
| † | K250630 | Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with… | 2025 |
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 21 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 glove is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric acid and Xylazine in Fentanyl Citrate in accordance with ASTM D6978-05 Standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs. NO. Chemotherapy Drugs Minimum Breakthrough Detection…
Read the full statement (249 words)
The glove is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner.
Gloves were tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric acid and Xylazine in Fentanyl Citrate in accordance with ASTM D6978-05 Standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
NO. Chemotherapy Drugs Minimum Breakthrough Detection Time
1 Carboplatin, 10 mg/ml >240 min.
2 Carmustine, 3.3 mg/ml 15.3 min.
3 Cisplatin, 1 mg/ml >240 min.
4 Cyclophosphamide, 20 mg/ml >240 min.
5 Cytarabine HCl, 100 mg/ml >240 min.
6 Dacarbazine, 10 mg/ml >240 min.
7 Daunorubicin HCl, 5 mg/ml >240 min.
8 Doxorubicin HCl, 2 mg/ml >240 min.
9 Etoposide, 20 mg/ml >240 min.
10 5-Fluorouracil, 50 mg/ml >240 min.
11 Gemcitabine HCl, 38 mg/ml >240 min.
12 Ifosfamide, 50 mg/ml >240 min.
13 Irinotecan HCl, 20 mg/ml >240 min.
14 Mechlorethamine HCl, 1 mg/ml >240 min.
15 Melphalan HCl, 5 mg/ml >240 min.
16 Methotrexate, 25 mg/ml >240 min.
17 Mitomycin-C, 0.5 mg/ml >240 min.
18 Mitoxantrone HCl, 2 mg/ml >240 min.
19 Pacilitaxel, 6 mg/ml >240 min.
20 Thiotepa, 10 mg/ml 28.2 min.
NO. Fentanyl, Gastric Acid and Xylazine Minimum Breakthrough Detection Time
1 Fentanyl Citrate Injection,50mcg/ml >240 min.
2 Gastric Acid >240 min.
3 Fentanyl Citrate (50mcg/ml): Xylazine HCl(100mg/ml), 50:50 >240 min.
*Please note that the following drugs have extremely low permeation times:
Carmustine: 15.3 minutes, Thiotepa: 28.2 minutes
Warning: Do not use with Carmustine and Thiotepa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251716: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251716
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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