# K183562: Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Encompass Industries Sdn. Bhd.
- Decided: Oct 23, 2019 after 307 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 powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, the glove was tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: The following chemotherapy drugs have been tested with the white glove: Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes Cyclophosphamide (Cytoxan) 20.0mg/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 Cisplatin 1.0mg/ml > 240 Dacarbazine (DTIC) 10.0mg/ml > 240 *Carmustine (BCNU) 3.3mg/ml 11.2 *Thiotepa (THT) 10.0mg/ml 25.2 *Please note that the following 2 drugs have extremely low permeation times: 1. Carmustine: 11.2 minutes 2. Thiotepa: 25.2 minutes Warning: Do not use with Carmustine (BCNU) and Thiotepa (THT). The following chemotherapy drugs have been tested with the blue glove: Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes Cyclophosphamide (Cytoxan) 20.0mg/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 Cisplatin 1.0mg/ml > 240 Dacarbazine (DTIC) 10.0mg/ml > 240 *Carmustine (BCNU) 3.3mg/ml 10.7 *Thiotepa (THT) 10.0mg/ml 21.5 *Please note that the following 2 drugs have extremely low permeation times: 1. Carmustine: 10.7 minutes 2. Thiotepa: 21.5 minutes Warning: Do not use with Carmustine (BCNU) and Thiotepa (THT). The following chemotherapy drugs have been tested with the black glove: Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes Cyclophosphamide (Cytoxan) 20.0mg/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 Cisplatin 1.0mg/ml > 240 Dacarbazine (DTIC) 10.0mg/ml > 240 *Carmustine (BCNU) 3.3mg/ml 11.0 *Thiotepa (THT) 10.0mg/ml 11.1 *Please note that the following 2 drugs have extremely low permeation times: 1. Carmustine: 11.0 minutes 2. Thiotepa: 11.1 minutes Warning: Do not use with Carmustine (BCNU) and Thiotepa (THT).

Source page: https://510kreport.com/device/K183562
Methodology: https://510kreport.com/methodology