# K190725: Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White

- Pathway: 510(k) (Traditional)
- Applicant: Riverstone Resources Sdn Bhd
- Decided: Dec 17, 2019 after 272 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: 5 generations back to K042805 (2004). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180452: White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim, Riverstone Resources Sdn Bhd (2018) Summary page 5.

## Most influential descendants
- K220250: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs (2022), 1 descendant of its own
- K232039: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (2023), 0 descendants of its own

## Indications for use
The Nitrile Examination gloves,is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards : Practice for assessment of medical Glove to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Concentration Minimum Breakthrough detection time in Minutes 1) Carmustine (BCNU)(3.3mg/ml) 39 minutes 2) Cyclophosphamide (20mg/ml) > 240 minutes 3) Cisplatin (l.0mg/ml) > 240 minutes 4) Doxorubicin Hydrochloride (2.0mg/ml) > 240 minutes 5) Etoposide (20mg/ml) > 240 minutes 6) Fluorouracil (50mg/ml) > 240 minutes 7) Methorexate (25mg/ml) > 240 minutes 8) Paclitaxel (6mg/ml) > 240 minutes 9) Thiotepa (10mg/ml) 97.6 minutes Caution: Thiotepa (l0mg/ml),Breakthrough Detected at 97.6 Minutes Carmustine (3.3mg/ml),Breakthrough Detected at 39 Minutes

Source page: https://510kreport.com/device/K190725
Methodology: https://510kreport.com/methodology