# K171782: Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs

- Pathway: 510(k) (Traditional)
- Applicant: Blue Sail Medical Co.,Ltd
- Decided: Oct 12, 2017 after 119 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
The Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs 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. The proposed device was tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The following chemicals have been tested with proposed device. Test Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes *Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 35.3 Cisplatin 1.0 mg/ml(1,000 ppm) >240 Cyclophosphamide (Cytoxan) 20 mg/ml(20,000 ppm) >240 Doxorubicin Hydrochloride 2.0 mg/ml(2,000 ppm) >240 Eotoside (Toposar) 20.0 mg/ml1(20,000 ppm) >240 Fluorouracil 50.0 mg/ml(50,000 ppm) >240 Mechlorethamine HCI 1.0 mg/ml(1,000 ppm) >240 Methotrexate 25.0 mg/ml(25,000 ppm) >240 Mitomycin C 0.5 mg/ml(500 ppm) >240 Paclitaxel (Taxol) 6.0 mg/ml(6,000 ppm) >240 *Thiotepa 10.0 mg/ml(10,000 ppm) 29.2 Vincristine Sulfate 1.0 mg/ml(1,000 ppm) >240 Please note that the following drugs have lower permeation times: Carmustine (BCNU): 35.3 minutes and Thiotepa: 29.2 minutes.

Source page: https://510kreport.com/device/K171782
Methodology: https://510kreport.com/methodology