ClearanceBrief
510(k) K001165 ยท LYY Latex Patient Examination Glove

POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

ApplicantMedipure Corporation (M) Sdn. Bhd., Kuala Kangsar, Perak, MY
DecisionSubstantially Equivalent, Jul 5, 2000
ReceivedApr 10, 2000
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K001165

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.