# K243133: Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid

- Pathway: 510(k) (Traditional)
- Applicant: Kl-Kepong Rubber Products Sdn. Bhd.
- Decided: Jun 17, 2025 after 260 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K042805 (2004). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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. (2024) Summary page 6.

## Indications for use
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

Source page: https://510kreport.com/device/K243133
Methodology: https://510kreport.com/methodology