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510(k) Data Aggregation
K Number
K964819Device Name
SHENG HO
Manufacturer
Date Cleared
1998-01-06
(400 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANG HO INDUSTRIAL CORP. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Device Description
Powder Free Latex Patient Examination Gloves
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K Number
K970795Device Name
SHANG HO
Manufacturer
Date Cleared
1997-12-18
(289 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SHANG HO INDUSTRIAL CORP. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Surgeon's Gloves is worn on the hand of operating room personnel to protect surgical wound from contamination and prevent contaimination between operating room personnel and patient.
Device Description
Powder Free SterikSurgeon's Gloves
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