510(k) K992337

BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA by Mexpo Intl., Inc. — Product Code FMC

K992337 is an FDA 510(k) premarket notification submitted by Mexpo Intl., Inc. for the device "BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA". The FDA issued a decision of Substantially Equivalent on August 17, 1999. The device falls under product code FMC (Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Mexpo Intl., Inc. has at least 3 other 510(k) clearances on record.