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510(k) Data Aggregation
K Number
K023139Device Name
ROMED LATEX SURGICAL GLOVES, POWDERED, STERILE
Manufacturer
Date Cleared
2003-10-22
(397 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
VAN OOSTVEEN MEDICAL B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ROMED surgeon sterile powdered gloves is a single use disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
The ROMED surgeon's gloves are made of natural rubber, sterile and powdered with USP absorbable dusting powder. E.P. content is less than 100 µg/gm. Surgeon's gloves are in conformity with ASTM D3577-00a standard.
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