# K230681: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl

- Pathway: 510(k) (Traditional)
- Applicant: Central Medicare Sdn Bhd
- Decided: Oct 2, 2023 after 203 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 is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner . In addition, these gloves were tested for use with chemotherapy drugs, with gastric acid and fentanyl citrate in accordance with ASTM D6978-05. Tested chemotherapy drugs and breakthrough detection time (minutes) are as follows: Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes Arsenic Trioxide 1.0mg/ml > 240minutes Azacitidine (Vidaza) 25.0mg/ml > 240minutes Bendamustine HCl 5.0mg/ml > 240minutes Bleomycin Sulfate 15.0mg/ml > 240minutes Busulfan 6.0mg/ml > 240minutes Carboplatin 10.0mg/ml > 240minutes Carmustine (BCNU) 3.3mg/ml 55.1minutes Carfilzomib 2.0mg/ml > 240minutes Cetuximab 2.0mg/ml > 240minutes Chloroquine 50.0mg/ml > 240minutes Cisplatin 1.0mg/ml > 240minutes Cladribine 1.0mg/ml > 240minutes Cyclophosphamide (Cytoxan) 20.0mg/ml > 240minutes Cyclosporin A 100.0mg/ml > 240minutes Cytarabine 100.0mg/ml > 240minutes Cytovene (Ganciclovir) 10.0mg/ml > 240minutes Dacarbazine 10.0mg/ml > 240minutes Daunorubicin 5.0mg/ml > 240minutes Decitibine 5.0mg/ml > 240minutes Docetaxel 10.0mg/ml > 240minutes Doxorubicin Hydrochloride 2.0mg/ml > 240minutes Epirubicin (Ellence) 2.0mg/ml > 240minutes Etoposide (Toposar) 20.0mg/ml > 240minutes Fludarabine 25.0mg/ml > 240minutes Fluorouracil 50.0mg/ml > 240minutes Fulvestrant 50.0mg/ml > 240minutes Gemcitabine (Gemzar) 38.0mg/ml > 240minutes Idarubicin 1.0mg/ml > 240minutes lfosfamide 50.0mg/ml > 240minutes Irinotecan 20.0mg/ml > 240minutes Mechlorethamine HCl 1.0mg/ml > 240minutes Melphalan 5.0mg/ml > 240minutes Mesna 50.0mg/ml > 240minutes Methotrexate 25.0mg/ml > 240minutes Mitomycin C 0.5mg/ml > 240minutes Mitoxantrone 2.0mg/ml > 240minutes Oxaliplatin 2.0 mg/ml > 240 minutes Paclitaxel 6.0 mg/ml > 240 minutes Paraplatin 10.0 mg/ml > 240 minutes Pemetrexed 25.0 mg/ml > 240 minutes Pertuzumab 30.0 mg/ml > 240 minutes Propofol 10.0 mg/ml > 240 minutes Raltitrexed 0.5 mg/ml > 240 minutes Retrovir 10.0 mg/ml > 240 minutes Rituximab 10.0 mg/ml > 240 minutes Temsirolimus 25.0 mg/ml > 240 minutes Thiotepa 10.0 mg/ml 98.7 minutes Topotecan HCl 1.0 mg/ml > 240 minutes Trastuzumab 21.0 mg/ml > 240 minutes Triclosan 2.0 mg/ml > 240 minutes Trisenox (Arsenic Trioxide) 1.0 mg/ml > 240 minutes Velcade (Bortezomib) 1.0 mg/ml > 240 minutes Vinblastine 1.0 mg/ml > 240 minutes Vincristine Sulfate 1.0 mg/ml > 240 minutes Vinorelbine 10.0 mg/ml > 240 minutes Zoledronic Acid 0.8 mg/ml > 240 minutes Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes. Under the testing conditions of ASTM D6978-05, Gastric Acid was found to have no breakthrough detected up to 240 minutes. CAUTION: Testing showed breakthrough time of 55.1 minutes with Carmustine and 98.7 minutes with Thiotepa. WARNING: Do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K230681
Methodology: https://510kreport.com/methodology