K Number
K011066Device Name
STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
2001-09-11
(155 days)
Product Code
Regulation Number
878.4460AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
More Information
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§ 878.4460 Non-powdered surgeon's glove.
(a)
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.(b)
Classification. Class I (general controls).
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