# K220401: Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim

- Pathway: 510(k) (Traditional)
- Applicant: Riverstone Resources Sdn Bhd
- Decided: Apr 9, 2022 after 57 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
Longest line of descent: 2 generations back to K183287 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192954: Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Comfort Rubber Gloves Industries Sdn. Bhd. (2020) Summary page 6.

## Indications for use
Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim is a disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use. In addition, these gloves were tested for use with Chemotherapy drug and Fentanyl test claim in accordance with ASTM D6978-05 standards. Practice for assessment of Medical Glove to Permeation by chemotherapy drug and Fentanyl test claim Chemotherapy Drugs and Concentration Minimum Breakthrough Detection Time (Min), ug/cm2/minute 1) Carmustine (BCNU) 3.3mg/ml 13.7 minutes 2) Cyclophosphamide (Cytoxan) (20mg/ml) >240 minutes 3) Cytarabine HCI (100mg/ml) >240 minutes 4) Doxorubicin HCI (2.0mg/ml) >240 minutes 5) Etoposide (20.Omg/ml >240 minutes 6) Fluorouracil (50.Omg/ml) >240 minutes 7) Methotrexate (25mg/mi) >240 minutes 8) Paclitaxel (6.Omg/ml) >240 minutes 9) ThioTepa (10.Omg/ml) 34.8 minutes 10) Fentanyl Citrate Injection 100mg/2ml >240 minutes The Maximum testing time is 240 minutes. Please note that the following drugs have extremely low Permeation time, Carmustine (BCNU) 3.3mg/ml ThioTeta (10.Omg/ml) Warning to do not use with Carmustine and Thio Tepa.

Source page: https://510kreport.com/device/K220401
Methodology: https://510kreport.com/methodology