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510(k) Data Aggregation
K Number
K984066Device Name
OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM
Manufacturer
Date Cleared
1999-01-13
(58 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
OMNI INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A glove to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
OmniGrip Latex Surgeons Gloves, Powder Free WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
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K Number
K984064Device Name
OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE
Manufacturer
Date Cleared
1999-01-08
(53 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
OMNI INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A glove to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Not Found
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