POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS)

POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS) is an FDA 510(k)-cleared medical device (K001327) manufactured by Premier Pathway Sdn. Bhd.. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 22, 2000. Regulation: 8.