# K220943: Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim

- Pathway: 510(k) (Traditional)
- Applicant: Eco Medi Glove Sdn. Bhd.
- Decided: Jul 19, 2022 after 110 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
A Powder Free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner for use with chemotherapy drug and Fentanyl Test Claim. In addition these gloves were tested for use with Chemotherapy drug and Fentanyl Citrate Tested claim in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by Chemotherapy drug and Fentanyl Citrate Tested Claim. Chemotherapy Drugs and Concentration Minimum Breakthrough Detection Time(Min), ug/cm2/minute 1) Carmustine (BCNU) 3.3mg/ml 28.8 minutes 2) Cyclophosphamide (Cytoxan) (20mg/ml) >240 minutes 3) Cytarabine HCI (100mg/ml) >240 minutes 4) Doxorubicin HCI (2.Omg/ml) >240 minutes 5) Etoposide (20.0mg/mi >240 minutes 6) Fluorouracil (50.0mg/ml) >240 minutes 7) Methotrexate (25mg/ml) >240 minutes 8) Paclitaxel (6.0mg/ml) >240 minutes 9) ThioTepa (10.0mg/ml) 57.6 minutes 10) Fentanyl Citrate Injection 100mg/2mi >240 minute The Maximum testing time is 240 minutes. Please note that the following drugs have extremely low Permeation time, Carmustine (BSNU) 3.3mg/ml Thio Tepa (10.Omg/ml) WARNING: Not for use with Carmustine or Thio Tepa Tested for use with Chemotherapy Drugs using ASTM D6978-05. Gloves used for protection against chemotherapy drug exposure must be selected specifically for the type of drugs being used.

Source page: https://510kreport.com/device/K220943
Methodology: https://510kreport.com/methodology