ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W

ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W is an FDA 510(k)-cleared medical device (K000217) manufactured by Shield Gloves Manufacturer (M) Sdn Bhd. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 17, 2000. Regulation: 8.