# K223752: Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl

- Pathway: 510(k) (Traditional)
- Applicant: Central Medicare Sdn Bhd
- Decided: Jul 24, 2023 after 221 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
Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, 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 chloroquine, cyclosporin A, retrovir, gastric acid and fentanyl citrate in accordance with ASTM D6978-05(2019). Tested chemotherapy drugs and average breakthrough detection time (minutes) are as follows: Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes 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 | 13.2 mins Cisplatin | 1.0 mg/ml | > 240 mins Cyclophosphamide (Cytoxan) | 20.0 mg/ml | > 240 mins Cytarabine (Cytosine) | 100.0 mg/ml | > 240 mins Dacarbazine | 10.0 mg/ml | > 240 mins Daunorubicin HCI | 5.0 mg/ml | > 240 mins Docetaxel | 10.0 mg/ml | > 240 mins Doxorubicin HCI | 2.0 mg/ml | > 240 mins Epirubicin HCI (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 Gemcitabine (Gemzar) | 38.0 mg/ml | > 240 mins Idarubicin HCI | 1.0 mg/ml | > 240 mins Ifosfamide | 50.0 mg/ml | > 240 mins Irinotecan | 20.0 mg/ml | > 240 mins Mechlorethamine HCl | 1.0 mg/ml | > 240 mins Melphalan | 5.0 mg/ml | > 240 mins Methotrexate | 25.0 mg/ml | > 240 mins Mitomycin C | 0.5 mg/ml | > 240 mins Mitoxantrone HCl | 2.0 mg/ml | > 240 mins Oxaliplatin | 5.0 mg/ml | > 240 mins Paclitaxel | 6.0 mg/ml | > 240 mins Paraplatin | 10.0 mg/ml | > 240 mins Rituximab | 10.0 mg/ml | > 240 mins Thiotepa | 10.0 mg/ml | 34.7 mins Topotecan HCI | 1.0 mg/ml | > 240 mins Trisenox (Arsenic Trioxide) | 1.0 mg/ml | > 240 mins Velcade (Bortezomib) | 1.0 mg/ml | > 240 mins Vincristine Sulfate | 1.0 mg/ml | > 240 mins Tested non-chemotherapy drugs and average breakthrough detection time (minutes) are as follows: Non-Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes Chloroquine | 50.0 mg/ml | > 240 mins Cyclosporin A | 100.0 mg/ml | > 240 mins Retrovir | 10.0 mg/ml | > 240 mins Fentanyl Permeation - Under the testing conditions of ASTM D6978-05(2019), Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes. Gastric Acid Permeation - Under the testing conditions of ASTM D6978-05(2019), was found to have no breakthrough detected up to 240 minutes. CAUTION: Testing showed an average breakthrough time of 13.2 minutes with Carmustine and 34.7 minutes with Thiotepa. WARNING: Do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K223752
Methodology: https://510kreport.com/methodology