# K992752: Surgeon's Gloves Pre-Powdered, Models 6.5, 7, 7.5, 8, 8.5

- Pathway: 510(k) (Traditional)
- Applicant: Pt. Maja Agung Latexindo
- Decided: Nov 5, 1999 after 81 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. The FDA summary names its predicate without a number.
- (no number) Class I Surgeon’s Gloves: named in the summary without a submission number

## Indications for use
A latex surgeon’s glove is a disposable device intended for medical purpose that is worn on surgeon's hand during surgical operation to prevent contamination between patient and surgeon.

Source page: https://510kreport.com/device/K992752
Methodology: https://510kreport.com/methodology