ClearanceBrief
510(k) K001216 ยท LYY Latex Patient Examination Glove

POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

ApplicantFitco Dipped Products Pvt., Ltd., Kerala, IN
DecisionSubstantially Equivalent, Apr 28, 2000
ReceivedApr 14, 2000
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K001216

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.