ClearanceBrief
510(k) K001959 ยท KGO Surgeon'S Gloves

POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

ApplicantHartalega Sdn Bhd, Kuala Lumpur, MY
DecisionSubstantially Equivalent, Jul 26, 2000
ReceivedJun 27, 2000
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K001959

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.