510(k) · Cleared
ClearedNon-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rubberex Alliance Products Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Aug 5, 2022 as substantially equivalent to K213227 (Uweport, LLC, 2022) after an 87-day review. Its family tree reaches back 9 generations to 2004.
- Decided
- Aug 5, 2022
- Review
- 87 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K042805 (2004). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 5 generations between
- 3 generations backK182600 Powder Free Nitrile Examination Glove, Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2018
- 2 generations backK210944 Powder Free Nitrile Examination Glove, Tested for Use with…Harbour Health, LLC · 2021
- 1 generation backK213227 Powder free Nitrile Examination Glove-(Test for use with…Uweport, LLC · 2022
- This deviceK221350 Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use…Rubberex Alliance Products Sdn Bhd · 2022
Show all 9 generations
- Root · 9 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 8 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 7 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 6 generations backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
- 5 generations backK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
- 4 generations backK173942 Blue Non Sterile powder free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2018
- 3 generations backK182600 Powder Free Nitrile Examination Glove, Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2018
- 2 generations backK210944 Powder Free Nitrile Examination Glove, Tested for Use with…Harbour Health, LLC · 2021
- 1 generation backK213227 Powder free Nitrile Examination Glove-(Test for use with…Uweport, LLC · 2022
- This deviceK221350 Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use…Rubberex Alliance Products Sdn Bhd · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −8 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −7 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −6 | K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | Hebei Hongsen Plastics Technology Co, Ltd. | 2017 | — |
| −5 | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2017 | — |
| −4 | K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2018 | — |
| −3 | K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs… | Better Care Plastic Technology Co., Ltd. | 2018 | — |
| −2 | K210944 | Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs… | Harbour Health, LLC | 2021 | — |
| −1 | K213227 | Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs) | Uweport, LLC | 2022 | — |
| 0 (this device) | K221350 | Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with… | Rubberex Alliance Products Sdn Bhd | 2022 | — |
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 |
|---|---|---|---|
| * | K213227 | Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)Summary page 5…I, reserved Product Code: LZA, LZC, OPJ 3. Information for the 510(k) Cleared Device (Predicate Device): Predicate device: K213227 Trade/Device Name: Uweport Powder-Free Nitrile Examination Gloves Tested for Use… | 2022 |
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 18 years and passes through 9 companies; a new generation was cleared every 9 months on median.
- None of the 10 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. 2022, 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?
Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs) is a non-sterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. List of…
Read the full statement (214 words)
Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs) is a non-sterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
List of Drugs tested concentration and breakthrough detection time in minutes. The maximum testing time is 240 minutes.
Drug Tested — Concentration — Breakthrough Detection Time in Minutes
Carmustine (BCNU) — 3.3 mg/mL (3300 ppm) — 14.6
Cisplatin — 1.0 mg/mL (1000 ppm) — > 240
Cyclophosphamide (Cytoxan@) — 20 mg/mL (20000 ppm) — > 240
Dacarbazine (DTCI) — 10 mg/mL (10000 ppm) — > 240
Doxorubicin Hydrochloride — 2.0 mg/mL (2000 ppm) — > 240
Etoposide (Toposar@) — 20 mg/mL (20000 ppm) — > 240
Fluorouracil — 50 mg/mL (50000 ppm) — > 240
Paclitaxel (Taxol@) — 6.0 mg/mL (6000 ppm) — > 240
Thiotepa — 10 mg/mL (10000 ppm) — 15.0
Warning: Do not use with Carmustine and Thiotepa.
Please note that the following drugs have low permeation times:
Camustine (BCNU) — 3.3 mg/mL (3300 ppm) — 14.6 minutes
Thiotepa — 10.0 mg/mL (10000 ppm) — 15.0 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221350 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221350: Non-Sterile Powder Free Nitrile Examination Gloves (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/K221350
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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