ClearanceBrief
510(k) K012135 ยท KGO Surgeon'S Gloves

POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

ApplicantWrp Asia Pacific Sdn. Bhd., Salak Tinggi, Sepang Selangor, MY
DecisionSubstantially Equivalent, Aug 1, 2001
ReceivedJul 9, 2001
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K012135

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.