# K211022: 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: Dec 22, 2021 after 261 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 examiner'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. Tested chemotherapy drugs and average breakthrough detection time (minutes) are as follows: Arsenic Trioxide 1.0 mg/ml >240 mins Azacitidine (Vidaza) 25.0 mg/ml > 240 mins Bendamustine HCI 5.0 mg/ml > 240 mins Bleomycin Sulfate 15.0 mg/ml > 240 mins Busulfan 6.0 mg/ml > 240 mins Carboplatin 10.0 mg/ml > 240 mins Carmustine (BCNU) 3.3 mg/ml 12.7 mins Carfilzomib 2.0 mg/ml > 240 mins Cetuximab 2.0 mg/ml > 240 mins Chloroquine 50.0 mg/ml > 240 mins Cisplatin 1.0 mg/ml > 240 mins Cladribine 1.0 mg/ml > 240 mins Cyclophosphamide (Cytoxan) 20.0 mg/ml > 240 mins Cyclosporin A 100.0 mg/ml > 240 mins Cytarabine 100.0 mg/ml > 240 mins Cytovene (Ganciclovir) 10.0 mg/ml > 240 mins Dacarbazine 10.0 mg/ml > 240 mins Daunorubicin 5.0 mg/ml > 240 mins Decitibine 5.0 mg/ml > 240 mins Docetaxel 10.0 mg/ml > 240 mins Doxorubicin Hydrochloride 2.0 mg/ml > 240 mins Epirubicin (Ellence) 2.0 mg/ml > 240 mins Etoposide (Toposar) 20.0 mg/ml > 240 mins Fludarabine 25.0 mg/ml > 240 mins Fluorouracil 50.0 mg/ml > 240 mins Fulvestrant 50.0 mg/ml > 240 mins Gemcitabine (Gemzar) 38.0 mg/ml > 240 mins Idarubicin 1.0 mg/ml > 240 mins Ifosfamide 50.0 mg/ml > 240 mins Irinotecan 20.0 mg/ml > 240 mins Mechlorethamine HCI 1.0 mg/ml > 240 mins Melphalan 5.0 mg/ml > 240 mins Mesna 50.0 mg/ml >240 mins Methotrexate 25.0 mg/ml > 240 mins Mitomycin C 0.5 mg/ml > 240 mins Mitoxantrone 2.0 mg/ml > 240 mins Oxaliplatin 2.0 mg/ml > 240 mins Paclitaxel 6.0 mg/ml > 240 mins Paraplatin 10.0 mg/ml > 240 mins Pemetrexed 25.0 mg/ml > 240 mins Pertuzumab 30.0 mg/ml >240 mins Propofol 10.0 mg/ml > 240 mins Raltitrexed 0.5 mg/ml > 240 mins Retrovir 10.0 mg/ml > 240 mins Rituximab 10.0 mg/ml > 240 mins Temsirolimus 25.0 mg/ml >240 mins Thiotepa 10 mg/ml 35.8 mins Topotecan HCI 1.0 mg/ml > 240 mins Trastuzumab 21.0 mg/ml >240 mins Triclosan 2.0 mg/ml > 240 mins Trisenox (Arsenic Trioxide) 1.0 mg/ml > 240 mins Velcade (Bortezomib) 1.0 mg/ml > 240 mins Vinblastine 1.0 mg/ml > 240 mins Vincristine Sulfate 1.0 mg/ml > 240 mins Vinorelbine 10.0 mg/ml > 240 mins Zoledronic Acid 0.8 mg/ml > 240 mins CAUTION: Testing showed an average breakthrough time of 35.8 minutes with Thiotepa and 12.7 minutes with Carmustine. WARNING: Do not use with Carmustine and Thiotepa. 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. 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/K211022
Methodology: https://510kreport.com/methodology