# K170290: Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr

- Pathway: 510(k) (Traditional)
- Applicant: Shen Wei USA, Inc.
- Decided: May 24, 2017 after 114 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 to prevent contamination in between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs: Chemotherapy Drug Permeation The following chemicals have been tested with these gloves. Chemotherapy Drug and Concentration Breakthrough Detection Time in Minutes Carmustine (BCNU), 3.3mg/ml 27.8 Cisplatin, 1.0mg/ml >240 Cyclophosphamide (Cytoxan), 20mg/ml >240 Cyclosporin A, 100 mg/ml >240 Dacarbazine (DTIC) 10g mg/ml >240 Doxorubicin Hydrochloride, 2.0 mg/ml >240 Etoposide (Toposar), 20mg/ml >240 Fluorouracil 50mg/ml >240 Paclitaxel (Taxol), 6.0mg/ml >240 Thiotepa, 10mg/ml 77.9 Vincristine Sulfate, 1.0mg/ml >240 Please note that the following drug has extremely low permeation times: Carmustine (BCNU): 27.8 minutes.

Source page: https://510kreport.com/device/K170290
Methodology: https://510kreport.com/methodology