510(k) Report

510(k) · Cleared

Cleared

Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid

K243133510(k) TraditionalCleared Jun 17, 2025260-day reviewClass I21 CFR 880.6250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Other ancestors, by year cleared 2005: 1 other ancestorK042805 · Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile · Perusahaan Getah Asas Sdn. Bhd. · 2004K081089 · Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim · Kimberly-Clark Corp. · 2008K141982 · Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs · Wrp Asia Pacific Sdn. Bhd. · 2015K163146 · POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs · Hebei Hongsen Plastics Technology Co, Ltd. · 2017K172525 · Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs · Central Medicare Sdn Bhd · 2017K180646 · Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs · Halyard Health · 2018K191230 · Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves · O&M Halyard, Inc. · 2019K231938 · Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid · O&M Halyard, Inc. · 2024200020052010201520202025
Other ancestors, by generation 8 generations back: 1 other ancestor K231938 · Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid · O&M Halyard, Inc. · 2024K191230 · Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves · O&M Halyard, Inc. · 2019K180646 · Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs · Halyard Health · 2018K172525 · Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs · Central Medicare Sdn Bhd · 2017K163146 · POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs · Hebei Hongsen Plastics Technology Co, Ltd. · 2017K141982 · Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs · Wrp Asia Pacific Sdn. Bhd. · 2015K081089 · Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim · Kimberly-Clark Corp. · 2008K042805 · Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile · Perusahaan Getah Asas Sdn. Bhd. · 2004−50
  1. Root · 8 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
  2. 7 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
  3. 6 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
  4. 5 generations backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
  5. 4 generations backK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
  6. 3 generations backK180646 Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with…Halyard Health · 2018
  7. 2 generations backK191230 Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling…O&M Halyard, Inc. · 2019
  8. 1 generation backK231938 Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis…O&M Halyard, Inc. · 2024
  9. 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

GenerationNumberDeviceApplicantDecidedRecalls
−8K042805Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-SterilePerusahaan Getah Asas Sdn. Bhd.2004—
−7K081089Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with…Kimberly-Clark Corp.2008—
−6K141982Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile…Wrp Asia Pacific Sdn. Bhd.2015—
−5K163146POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy DrugsHebei Hongsen Plastics Technology Co, Ltd.2017—
−4K172525Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with…Central Medicare Sdn Bhd2017—
−3K180646Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with…Halyard Health2018—
−2K191230Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG*…O&M Halyard, Inc.2019—
−1K231938Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential…O&M Halyard, Inc.2024—
0 (this device)K243133Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested…Kl-Kepong Rubber Products Sdn. Bhd.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K243133, 2004–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K231938Halyard 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…
O&M Halyard, Inc.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 devices

LZA 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

2007: 212008: 182009: 282010: 312011: 262012: 332013: 202014: 272015: 202016: 302017: 442018: 222019: 252020: 302021: 1392022: 1462023: 622024: 302025: 242026 (partial year): 15
2007high 146 (2022) · low 18 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZA

110in 2025

2007: 95 days median2008: 97 days median2009: 112 days median2010: 97 days median2011: 122 days median2012: 110 days median2013: 130 days median2014: 197 days median2015: 112 days median2016: 171 days median2017: 124 days median2018: 178 days median2019: 212 days median2020: 101 days median2021: 111 days median2022: 111 days median2023: 92 days median2024: 89 days median2025: 110 days median2026 (partial year): 103 days median
2007high 212 (2019) · low 89 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZA

3so far in 2026, the most since 2007

2015: 12016: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZA

73in 2025

2007: 72008: 22009: 122010: 122011: 92012: 112013: 102014: 82015: 122016: 252017: 42018: 32019: 212020: 42021: 202022: 192023: 242024: 762025: 73
2007high 76 (2024) · low 2 (2008)2025

MAUDE reports naming product code LZA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007219507
2008189702
200928112012
20103197012
20112612209
201233110011
201320130010
20142719708
201520112112
201630171125
20174412404
20182217803
201925212021
20203010104
2021139111020
2022146111019
20236292024
20243089076
202524110073
2026151033—

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.

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