# K981947: Sterile Powder Free Nitrile Surgeons Gloves (Natural, Blue and Green)

- Pathway: 510(k) (Traditional)
- Applicant: Boston Medical Corp.
- Decided: Mar 3, 1999 after 273 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
A SURGEON’S GLOVE IS A DEVICE MADE OF NATURAL OR SYNTHETIC RUBBER INTENDED TO BE WORN BY OPERATING ROOM PERSONNEL TO PROTECT A SURGICAL WOUND FROM CONTAMINATION.

Source page: https://510kreport.com/device/K981947
Methodology: https://510kreport.com/methodology