LATEX SURGICAL GLOVES

K892922 · Millimax Corp. · KGO · Nov 21, 1989 · General, Plastic Surgery

Device Facts

Record IDK892922
Device NameLATEX SURGICAL GLOVES
ApplicantMillimax Corp.
Product CodeKGO · General, Plastic Surgery
Decision DateNov 21, 1989
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.4460
Device ClassClass 1

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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