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510(k) Data Aggregation
K Number
K013980Device Name
SAFE SHIELD PRE-POWDERED LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2002-06-06
(185 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SAFE SHIELD CO. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Pre-Powdered Latex Examination Glove is a disposable device that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Patient Examination Gloves are a Class I device 21 CFR 880. These gloves are pre-powdered with a PMA approved Corn Starch Powder. They are used for wearing on hands of healthcare providers to prevent contamination from patient's or external environment.
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K Number
K020053Device Name
SAFE SHIELD POWEDER-FREE LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2002-05-01
(113 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SAFE SHIELD CO. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Powder-Free Latex Examination Glove is a disposable device that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Patient Examination Gloves are a Class I device 21 CFR 880. They are used for wearing on hands of healthcare providers to prevent contamination from patient's or external environment.
The standards that are followed are as follows: ASTM 3578-00 and Food and Drug requirements for Patient Examination Gloves.
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