# K262542: Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim

- Pathway: 510(k) (Special)
- Applicant: Top Glove Sdn. Bhd.
- Decided: Sep 9, 2026 after 48 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Biodegradable Nitrile Powder Free Examination Glove, Green A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 standard practice for assessment of medical gloves to permeation by chemotherapy drugs: Chemotherapy Drug Permeation: The following chemicals have been tested with these gloves. Chemotherapy Drugs Concentration Breakthrough Detection Time in Minutes Amethopterine 25.0 mg/ml > 240 Bleomycin Sulfate 15.0 mg/mi > 240 Busulfan 6.0 mg/ml > 240 Carboplatin 10.0 mg/mi > 240 Carmustine (BCNU) 3.3 mg/ml 10.0 Ciplastin 1.0 mg/ml > 240 Cyclophosphamide (Cytoxan) 20.0 mg/mi > 240 Cytarabine HCL (Cytosine) 100.0 mg/ml > 240 Dacarbazine (DTIC) 10.0 mg/mi > 240 Docetaxel (Taxotere) 10.0 mg/mi > 240 Doxorubicin Hydrochloride 2.0 mg/mi > 240 Epirubicin 2.0 mg/mi > 240 Etoposide 20.0 mg/ml > 240 Fludarabine 25.0 mg/ml > 240 Fluorouracil 50.0 mg/ml > 240 Gemicitabine 38.0 mg/ml > 240 Idarubicin 1.0 mg/mi > 240 Ifosfamide 50.0 mg/ml > 240 Irinotecan 20.0 mg/ml > 240 Mechlorethamine 1.0 mg/mi > 240 Melphalan 5.0 mg/mi > 240 Methotrexate 25.0 mg/ml > 240 Mitomycin C 0.5 mg/mi > 240 Mitoxantrone 2.0 mg/mi > 240 Oxaliplatin 5.0 mg/ml > 240 Paclitaxel 6.0 mg/mi > 240 Rituximab 10.0 mg/mi > 240 Thiotepa 10.0 mg/mi 60.0 Topotecan 1.0 mg/mi > 240 Trisenox 1.0 mg/mi > 240 Vincristine Sulfate 1.0 mg/ml > 240 Vinorelbine 10.0 mg/ml > 240 Please note that Carmustine and Thiotepa have extremely low permeation times of 10 minutes and 60 minutes respectively. Warning: Do not use with Carmustine and Thiotepa Simulated Gastric Acid Permeation Resistance Claim- Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes. Fentanyl Permeation Resistance Claim- Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2ml) was found to have no breakthrough detected up to 240 minutes.

Source page: https://510kreport.com/device/K262542
Methodology: https://510kreport.com/methodology