ClearanceBrief
510(k) K242689 ยท QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

AAMI Level 4 Protective; Gown

ApplicantAzac Group, City Of Industry CA, US
DecisionSubstantially Equivalent, Jan 13, 2025
ReceivedSep 6, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K242689

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.