ClearanceBrief
510(k) K230610 ยท FYA Gown, Surgical

Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)

ApplicantDongguan Shin YI Healthcare Products Factory, Dong Guan, CN
DecisionSubstantially Equivalent, Aug 23, 2023
ReceivedMar 6, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K230610

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.