# K200581: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega NGC Sdn. Bhd.
- Decided: Apr 25, 2020 after 51 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.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices 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.

## Most influential descendants
- K223437: Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) (2023), 1 descendant of its own
- K232070: Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) (2023), 0 descendants of its own
- K231567: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) (2023), 0 descendants of its own
- K231643: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (2023), 0 descendants of its own
- K211003: SHOWA (R) Blue Nitrile Powder Free Medical Examination Glove (2022), 0 descendants of its own

## Indications for use
Biodegradable Nitrite Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a non-sterile disposable device intended for medical purpose that is wom 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 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) 21.4 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (20.0 mg/ml) >240 Dacarbazine (10.0 mg/ml) >240 Doxorubicin Hydro'chloride (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 Paclitaxcl (6.0 mg/ml) >240 Thiotepa (10.0 mg/ml) 67.2 Vincristine Sulfate ( 1.0 mg/ml) >240 Azacytidine (25.0 mg/m1) >240 Carboplatin (10.0 mg/ml) >240 Docetaxel ( 10 mg/ml) >240 Epirubicin (2.0 mglmJ) >240 Gemcitabine (38 nig/ml) >240 Ifosfamide {50 mg/ml) >240 Irinotecan (20 mg/ml) >240 Mitoxantrone (2.0 mg/ml) >240 Oncovin (l.0 mg/ml) >240 Oxaliplatin (5 mg/ml) >240 Vinorelbine (] 0 mg/ml) >240 Please note that Cannustine and Thiotcpa have extremely low penneation times of 21.4 minutes and 67 .2 minutes respectively. Warning: Do not use with Carmustine Fcntanyl Citrate and Concentration Minimum Breakthrough Detection Time in Minutes Fentanyl Citrate Injection (100 mcg/2ml) >240

Source page: https://510kreport.com/device/K200581
Methodology: https://510kreport.com/methodology