# K230875: 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: Jul 20, 2023 after 112 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. In addition, these gloves were tested for use with chemotherapy drugs, with gastric acid and fentanyl citrate in accordance with ASTM D6978-05. 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 minutes; Azacitidine (Vidaza) (25.0 mg/ml): > 240 minutes; Bendamustine HCl (5.0 mg/ml): > 240 minutes; Bleomycin Sulfate (15.0 mg/ml): > 240 minutes; Busulfan (6.0 mg/ml): > 240 minutes; Carboplatin (10.0 mg/ml): > 240 minutes; Carmustine (BCNU) (3.3 mg/ml): 77.6 minutes; Carfilzomib (2.0 mg/ml): > 240 minutes; Cisplatin (1.0 mg/ml): > 240 minutes; Cladribine (1.0 mg/ml): > 240 minutes; Cyclophosphamide (Cytoxan) (20.0 mg/ml): > 240 minutes; Cytarabine (100.0 mg/ml): > 240 minutes; Dacarbazine (10.0 mg/ml): > 240 minutes; Daunorubicin (5.0 mg/ml): > 240 minutes; Decitibine (5.0 mg/ml): > 240 minutes; Docetaxel (10.0 mg/ml): > 240 minutes; Doxorubicin Hydrochloride (2.0 mg/ml): > 240 minutes; Epirubicin (Ellence) (2.0 mg/ml): > 240 minutes; Etoposide (Toposar) (20.0 mg/ml): > 240 minutes; Fludarabine (25.0 mg/ml): > 240 minutes; Fluorouracil (50.0 mg/ml): > 240 minutes; Gemcitabine (Gemzar) (38.0 mg/ml): > 240 minutes; Idarubicin (1.0 mg/ml): > 240 minutes; Ifosfamide (50.0 mg/ml): > 240 minutes; Irinotecan (20.0 mg/ml): > 240 minutes; Mechlorethamine HCI (1.0 mg/ml): > 240 minutes; Melphalan (5.0 mg/ml): > 240 minutes; Mesna (50.0 mg/ml): > 240 minutes; Methotrexate (25.0 mg/ml): > 240 minutes; Mitomycin C (0.5 mg/ml): > 240 minutes; Mitoxantrone (2.0 mg/ml): > 240 minutes; 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; Raltitrexed (0.5 mg/ml): > 240 minutes; Retrovir (10.0 mg/ml): > 240 minutes; Temsirolimus (25.0 mg/ml): > 240 minutes; Thiotepa (10.0 mg/ml): > 240 minutes; Topotecan HCI (1.0 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. Tested non-chemotherapy drugs and average breakthrough detection time (minutes) are as follows: Cetuximab (2.0 mg/ml): > 240 minutes; Chloroquine (50.0 mg/ml): > 240 minutes; Cyclosporin A (100.0 mg/ml): > 240 minutes; Cytovene (Ganciclovir) (10.0 mg/ml): > 240 minutes; Fulvestrant (50.0 mg/ml): > 240 minutes; Propofol (10.0 mg/ml): > 240 minutes; Rituximab (10.0 mg/ml): > 240 minutes; Trastuzumab (21.0 mg/ml): > 240 minutes; Triclosan (2.0 mg/ml): > 240 minutes; Zoledronic Acid (0.8 mg/ml): > 240 minutes. Fentanyl Permeation Resistance Claims - 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 Claims - Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes. CAUTION: Testing showed an average breakthrough time of 77.6 minutes with Carmustine. WARNING: Do not use with Carmustine.

Source page: https://510kreport.com/device/K230875
Methodology: https://510kreport.com/methodology