# K213437: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims

- Pathway: 510(k) (Traditional)
- Applicant: Central Medicare Sdn Bhd
- Decided: Apr 11, 2022 after 171 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
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examinet's hand to prevent contamination between patient and examiner. Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results. The following drugs and concentrations have been tested and reached the minimum breakthrough result of >240 minutes: Arsenic Trioxide 1.0; Azacitidine (Vidaza) 25.0; Bendamustine HCI 5.0; Bleomycin Sulfate 15.0; Busulfan 6.0; Carboplatin 10.0; Carfilzomib 2.0; Cetuximab 2.0; Chloroquine 50.0; Cisplatin 1.0; Cladribine 1.0; Cyclophosphamide (Cytoxan) 20.0; Cyclosporin A 100.0; Cytarabine 100.0; Cytovene (Ganciclovir) 10.0; Dacarbazine 10.0; Daunorubicin 5.0; Decitibine 5.0; Docetaxel 10.0; Doxorubicin Hydrochloride 2.0; Epirubicin (Ellence) 2.0; Etoposide (Toposar) 20.0; Fludarabine 25.0; Fluorouracil 50.0; Fulvestrant 50.0; Gemcitabine (Gemzar) 38.0; Idarubicin 1.0; Ifosfamide 50.0; Irinotecan 20.0; Mechlorethamine HCI 1.0; Melphalan 5.0; Mesna 50.0; Methotrexate 25.0; Mitomycin C 0.5; Mitoxantrone 2.0; Oxaliplatin 2.0; Paclitaxel 6.0; Paraplatin 10.0; Pemetrexed 25.0; Pertuzumab 30.0; Propofol 10.0; Raltitrexed 0.5; Retrovir 10.0; Rituximab 10.0; Temsirolimus 25.0; Topotecan HCI [.0; Trastuzumab 21.0; Triclosan 2.0; Trisenox (Arsenic Trioxide) [.0; Velcade (Bortezomib) 1.0; Vinblastine 1.0; Vincristine Sulfate [.0; Vinorelbine 10.0; Zoledronic Acid 0.8. The following drugs have permeation times lower than 240 minutes: Carmustine: 55.1 minutes and Thiotepa: 199.2 minutes. Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100meg/2mL) was found to have no breakthrough detected up to 240 minutes. Gastric Acid Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.

Source page: https://510kreport.com/device/K213437
Methodology: https://510kreport.com/methodology