# K171279: Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Top Glove Sdn. Bhd.
- Decided: Oct 12, 2017 after 164 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- 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
Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs is to be wotn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient. These gloves are tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug Permeation The following chemicals have been tested with these gloves. Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes Carmustin (BCNU) 3.3mg/ml 8.0 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 16.2 * Please note that the following drugs have extremely low permeation times: Carmustin (BCNU) : 8.0 minutes and Thiotepa : 16.2 minutes Sterile Latex Surgical Powder Free Gloves is to be worn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient.

Source page: https://510kreport.com/device/K171279
Methodology: https://510kreport.com/methodology