# K173766: PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Shen Wei USA, Inc.
- Decided: Jul 8, 2018 after 209 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 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 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. This device is single use only. Chemotherapy Drug and Concentration Breakthrough Detection Time in Minutes 1. Carmustine (BCNU), 3.3mg/ml 27.1 2. Cisplatin, 1.0mg/ml >240 3. Cyclophosphamide (Cytoxan), 20mg/ml >240 4. Dacarbazine (DTIC) 10g mg/ml >240 5. Doxorubicin Hydrochloride, 2.0 mg/ml >240 6. Etoposide (Toposar), 20mg/ml >240 7. Fluorouracil 50mg/ml >240 8. Paclitaxel (Taxol), 6.0mg/ml >240 9. Thiotepa, 10mg/ml 274 *Please note that Carmustine (BCNU) has low permeation time of 27.1 minutes and Thiotepa has permeation time of 27.4 minutes. WARNING: Do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K173766
Methodology: https://510kreport.com/methodology