# K183536: Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega NGC Sdn. Bhd.
- Decided: Aug 16, 2019 after 240 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
Latex Powder Free Surgical Glove With Protein Labelling Claim of 50 Microgram or Less per Gram of Glove is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K183536
Methodology: https://510kreport.com/methodology