# K171276: Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Tg Medical Sdn. Bhd.
- Decided: Aug 21, 2017 after 112 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
This powder free surgeon's gloveis a dispesable device made of synthetic rubber intended to be worn by operating room ‘persennel to pratect a surgical wound from contamination. T addition, these gloves weré tested for use with Chemotherapy Drugs in accordance ASTM D6978-05(2013) Standard ‘Practice for Assessment of Medieal Gloves to Permession by Chemotherapy Driigs. Chemp 'j,exa;‘:@y‘br’ugs’Penne'atien | raugh Detection Time) in Minutes L The faflowmg chemicals have been tested with thess glaves, Clonceniration Breakthrough Detection Tine in Minutes 3.3mg/m! 3.0 20.0mg/m! >240 2:0mg/ml »340 50.0mg/ml 244 25.0mg/mi >240 6.0mg/m! 5240 i 10.0mg/mi 24.9 Vine stme Bulfate 1.0nig/m} 240 owing ditigs have low permeation times: 3.0 minutes.and Thiotepa: 24:9- - Please note th Carmustine {BCNU

Source page: https://510kreport.com/device/K171276
Methodology: https://510kreport.com/methodology