# K190454: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega NGC Sdn. Bhd.
- Decided: Sep 26, 2019 after 213 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
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner, It is also tested to be used against Chemotherapy Drugs and Fentany! Citrate. These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes Carmustine (3.3 mg/ml) 2.73 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (20.0 mg/ml) >240 Dacarbazine (10.0 mg/ml) >240 Doxorubicin Hydrochloride (2.0 mg/ml) >240 Etoposide (20.0 mg/ml) >240 Fluorouracil (50.0 mg/ml) >240 Methotrexate (25.0 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Paclitaxel (6.0 mg/ml) >240 Thiotepa (10.0 mg/ml) 22.82 Vincristine Sulfate (1.0 mg/ml) >240 Please note that Carmustine and Thiotepa have extremely low permeation times of 2.73 minutes and 22.82 minutes respectively. Fentanyl Citrate and Concentration Minimum Breakthrough Detection Time in Minutes Fentanyl Citrate Injection (100 mcg/2ml) >240 WARNING: Do Not Use With: Carmustine and Thiotepa Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) - Extended Cuff is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also-tested to be used against Chemotherapy Drugs and Fentanyl Citrate. These gloves were tested for use with chemotherapy drugs and Fentany] Citrate as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes Carmustine (3.3 mg/ml) 30.2 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (20.0 mg/ml) >240 Dacarbazine (10.0 mg/ml) >240 Doxorubicin Hydrochloride (2.0 mg/ml) >240 Etoposide (20.0 mg/ml) >24(0 Fluorouracil (50.0 mg/ml) >240 Methotrexate (25.0 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Paclitaxel (6.0 mg/ml) >240 Thiotepa (10.0 mg/ml) 61.5 Vincristine Sulfate (1.0 mg/ml) >240 Please note that Carmustine and Thiotepa have extremely low permeation times of 30.2 minutes and 61.5 minutes respectively. Fentanyl Citrate and Concentration Minimum Breakthrough Detection Time in Minutes Fentanyl Citrate Injection (100 nicg/2ml) >240 WARNING: Do Not Use With: Carmustine and Thiotepa

Source page: https://510kreport.com/device/K190454
Methodology: https://510kreport.com/methodology