# K222350: Sterile Nitrile Surgical Gloves Powder Free

- Pathway: 510(k) (Abbreviated)
- Applicant: Jr Engineering & Medical Technologies (M) Sdn. Bhd.
- Decided: Apr 13, 2023 after 253 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
Longest line of descent: 5 generations back to K013302 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170515: Sterile Nitrile Surgical Gloves, Powder-free, Primus Gloves Pvt Limited (2017) Summary page 4.

## Indications for use
A Sterile Nitrile Surgical Gloves Powder Free is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K222350
Methodology: https://510kreport.com/methodology