# K162858: Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest

- Pathway: 510(k) (Traditional)
- Applicant: Careplus (M) Sdn Bhd
- Decided: Jul 24, 2017 after 285 days
- Product code: LZC (Medical Glove, Specialty)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K211666: Powder Free Nitrile Examination Gloves, Blue Chemotest (2022), 0 descendants of its own

## Indications for use
A 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. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drugs Permeation The following chemicals have been tested with these gloves. Chemotherapy Concentration Minimum Breakthrough Detection Time (min) Fluorouracil (Adrucil) 50.0mg/ml >240 Etopside(Toposar) 20.0mg/ml >240 Cyclophosphamide(Cytoxan) ~ 20.0mg/ml >240 *Carmustine(BCNU) 3.3mg/ml 10.2 *Thiotepa 10.0mg/ml 40.5 Paclitaxel(Taxol) 6.0mg/ml >240 Doxorubicin Hydrochloride(Adriamycin) 2.0mg/ml - >240 Dacarbazine 10.0mg/ml - >240 Cisplatin 1.0mg/ml >240 Ifosfamide 50.0mg/ml >240 Mitoxantrone 2.0mg/ml - >240 Vincristine Sulfate 1.0mg/ml >240 *Please note that following drugs have extremely low permeation times: Carmustine (BCNU) :10.2 minutes and Thiotepa:40.5 minutes

Source page: https://510kreport.com/device/K162858
Methodology: https://510kreport.com/methodology