510(k) · Cleared
ClearedNitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kl-Kepong Rubber Products Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Jun 17, 2025 as substantially equivalent to K231938 (O&M Halyard, Inc., 2024) after a 260-day review. Its family tree reaches back 8 generations to 2004.
- Decided
- Jun 17, 2025
- Review
- 260 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K042805 (2004). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 7 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 6 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 5 generations backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
- 4 generations backK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
- 3 generations backK180646 Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with…Halyard Health · 2018
- 2 generations backK191230 Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling…O&M Halyard, Inc. · 2019
- 1 generation backK231938 Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis…O&M Halyard, Inc. · 2024
- This deviceK243133 Nitrile Powder Free Examination Gloves with Low Dermatitis…Kl-Kepong Rubber Products Sdn. Bhd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −7 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −6 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −5 | K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | Hebei Hongsen Plastics Technology Co, Ltd. | 2017 | — |
| −4 | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2017 | — |
| −3 | K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with… | Halyard Health | 2018 | — |
| −2 | K191230 | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG*… | O&M Halyard, Inc. | 2019 | — |
| −1 | K231938 | Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential… | O&M Halyard, Inc. | 2024 | — |
| 0 (this device) | K243133 | Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested… | Kl-Kepong Rubber Products Sdn. Bhd. | 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 |
|---|---|---|---|
| * | K231938 | Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for…Summary page 6…ion Number: 21 CFR 880.6250 Panel: General Hospital 4. Predicate Device Information: Predicate Device: K231938 Trade/Device Name: Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low… | 2024 |
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 8 companies; a new generation was cleared every 2.0 years on median.
- None of the 9 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?
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, fentanyl citrate and gastric acid as per ASTM D6978-05 (2023) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: The following drugs and concentration had NO breakthrough…
Read the full statement (314 words)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand to
prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, fentanyl citrate and gastric acid as per ASTM D6978-05
(2023) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
The following drugs and concentration had NO breakthrough detected up to 240 minutes:
Bendamustine HCI (5 mg/mL)
Bleomycin Sulfate (15 mg/mL)
Busulfan (6 mg/mL)
Carboplatin (10 mg/mL)
Carfilzomib (2 mg/mL)
Cetuximab (Erbitux) (2 mg/mL)
Chloroquine (50 mg/mL)
Cisplatin (1 mg/mL)
Cladribine (1 mg/mL)
Cyclophosphamide (20 mg/mL)
Cyclosporin A (100 mg/mL)
Cytarabine HCI (100 mg/mL.)
Cytovene (10 mg/mL)
Dacarbazine (10 mg/mL)
Daunorubicin HCI (5 mg/mL)
Decitabine (5 mg/mL)
Docetaxel (10 mg/mL)
Doxorubicin HCI (2 mg/mL)
Epirubicin HCI (2 mg/mL)
Etoposide (20 mg/mL)
Fludarabine Phosphate (25 mg/mL)
Fluorouracil (50 mg/mL)
Fulvestrant (50 mg/mL)
Gemcitabine HCI (38 mg/mL)
Idarubicin HCI (1 mg/mL)
Ifosfamide (50 mg/mL)
Irinotecan HCI (20 mg/mL)
Mechlorethamine HCI (1 mg/mL)
Melphalan HCI (5 mg/mL)
MESNA (100 mg/mL)
Methotrexate (25 mg/mL)
Mitomycin C (0.5 mg/mL)
Mitoxantrone HCI (2 mg/mL)
Oxaliplatin (2 mg/mL)
Paclitaxel (6 mg/mL)
Pemetrexed (25 mg/mL)
Propofol (10 mg/mL)
Raltitrexed (0.5 mg/mL)
Retrovir (10 mg/mL)
Rituximab (10 mg/mL)
Temsirolimus (25 mg/mL)
Topotecan HCI (1 mg/mL)
Triclosan (1 mg/mL)
Trisenox (Arsenic Trioxide) (1 mg/mL)
Velcade (Bortezomib) (1 mg/mL)
Vidaza (Azacitidine) (25 mg/mL)
Vinblastine Sulfate (1 mg/mL)
Vincristine Sulfate (1 mg/mL)
Vinorelbine Tartrate (10 mg/mL)
Zoledronic Acid (0.8 mg/mL)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes:
Carmustine (3.3 mg/mL), breakthrough detected at 55.5 minutes
Thiotepa (10 mg/mL), breakthrough detected at 50.8 minutes
Warning: Not recommended for use with Carmustine and Thiotepa
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
Fentanyl Citrate Injection (100mcg/2mL)
Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243133: Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243133
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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