# K163017: Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Gmp Medicare Sdn. Bhd.
- Decided: Mar 22, 2017 after 145 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.
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. 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 (Breakthrough Detection Time) in Minutes The following chemicals have been tested with these gloves. Chemotherapy Drugs Concentration Breakthrough Detection Time in Minutes Carmustine (BCNU) 3.3mg/ml 11.1 Cisplatin 1.0mg/ml > 240 Cyclophosphamide (Cytoxan) 20.0mg/ml >240 Dacarbazine (DTIC) 10.0mg/ml > 240 Doxorubicin Hydrochloride 2.0mg/ml > 240 Etoposide (Toposar) 20.0mg/ml > 240 Fluorouracil 50.0mg/ml > 240 Paclitaxel (Taxol) 6.0mg/ml > 240 Thiotepa 10.0mg/ml 40.1 Amethopterin Hydrate 25.0mg/ml > 240 Methotrexate 25.0mg/ml > 240 Mitomycin C 0.5mg/ml >240 Vincristine Sulfate 1.0mg/ml > 240 *Please note that the following drugs have low permeation times: Carmustine (BCNU): 1 1.1 minutes and Thiotepa:40.1 minutes

Source page: https://510kreport.com/device/K163017
Methodology: https://510kreport.com/methodology