# K982957: Sensiflex Powderfree Surgeon's Glove

- Pathway: 510(k) (Traditional)
- Applicant: Terang Nusa Sdn Bhd
- Decided: Jan 13, 1999 after 142 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- Recalls of this device: 1 (0 Class I)
- 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. The FDA summary names its predicate without a number.
- (no number) Sur-G Glov: named in the summary without a submission number

## Recalls of this device
- May 23, 2006 · Not classified · Z-1185-06: The sterile glove pouches may have an open seal at the bottom of the pouch.

## Indications for use
A surgeon’s glove is a device made of natural of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination

Source page: https://510kreport.com/device/K982957
Methodology: https://510kreport.com/methodology