# K172923: Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue

- Pathway: 510(k) (Traditional)
- Applicant: Top Glove Sdn. Bhd.
- Decided: Apr 26, 2018 after 213 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 patient examination glove 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. A patient examination glove 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. A patient examination glove 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. A patient examination glove 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. 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 Drug Permeation The following chemicals have been tested with these gloves. Chemotherapy Drugs Concentration Breakthrough Detection Time in Minutes Carmustine (BCNU) 3.3 mg/mi 15.9 Ciplastin 1.0 mg/ml > 240 Cyclophospharmide (Cytoxan) 20.0 mg/mIl > 240 Dacarbazine (DTIC) 10.0 mg/ml > 240 Doxorubicin Hydrochloride 2.0 mg/m > 240 Etoposide (Toposar) 20.0 mg/mIl > 240 Fluorouracil 50.0 mg/ml > 240 Paclitaxel (Taxol) 6.0 mg/mlI > 240 Thiotepa 10.0 mg/ml 47.3 Please note that the following drugs have low permeation time Carmustine (BCNU): 15.9 minutes and Thiotepa: 47.3 minutes

Source page: https://510kreport.com/device/K172923
Methodology: https://510kreport.com/methodology