Product code KGO

Device name

Surgeon'S Gloves

Medical specialty

General, Plastic Surgery

Device class

1

Regulation number

878.4460

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Source

FDA openFDA device classification dataset