# K160928: Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega Sdb. Bhd.
- Decided: Dec 20, 2016 after 260 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 Polymer Coated Powder Free Surgical Glove With Protein Labeling Claim of 50 Microgram or Less per Gram of Glove (Natural) is made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. Latex Polymer Coated Powder Free Surgical Glove With Protein Labeling Claim of 50 Microgram or Less per Gram of Glove (Green) is made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K160928
Methodology: https://510kreport.com/methodology