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510(k) Data Aggregation
K Number
K972277Device Name
DIGIFLEX SURGICAL GLOVES
Manufacturer
Date Cleared
1997-10-21
(125 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
HMS SERVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Surgical Glove is a device made of natural or Synthetic rubber, intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Sterile Surgical Glove ( POWDERE
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