# K010198: Sterile Powdered Latex Surgeon Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Supermax Glove Manufacturing Sdn Bhd
- Decided: Feb 23, 2001 after 32 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Source page: https://510kreport.com/device/K010198
Methodology: https://510kreport.com/methodology