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510(k) Data Aggregation
K Number
K012067Device Name
CLINCARE LATEX SURGEON'S GLOVE
Manufacturer
Date Cleared
2001-09-17
(77 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
TTK HEALTHCARE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This Surgeon's Glove is a device made of natural rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination
Device Description
CLINCARE Latex Surgical Gloves are class I powdered surgeon's gloves, powdered with absorbable dusting powder, and meet all the requirements of ASTM D 3577.
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