Search Results
Found 3 results
510(k) Data Aggregation
K Number
K991304Device Name
HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Manufacturer
Date Cleared
1999-06-23
(68 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
M.R.G. INDUSTRIES SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HEALTH + AID PREMIUM Powderfree Nitrike Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
Device Description
HEALTH + AID® PREMIUM Powder Free Nitrile Examination Gloves meet all the current specification listed under the ASTM Specification Examination Gloves, EXCEPT for ultimate elongation before ageing. They are blue or natural white in colour and are powder free.
Ask a Question
Ask a specific question about this device
K Number
K991305Device Name
HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
1999-06-21
(66 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
M.R.G. INDUSTRIES SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HEALTH + AID @ PREMIUM Powderfree Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contanination between the health care personnel and the patient.
Device Description
HEALTH + AID ® PREMIUM Powder Free Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves. They are natural white in colour and are powder free.
Ask a Question
Ask a specific question about this device
K Number
K981893Device Name
HEALTH + AID PREMIUM PRE-POWDERED LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
1998-06-22
(24 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
M.R.G. INDUSTRIES SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HEALTH + AID® PREMIUM Pre-powdered Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
100mcg/gm or less total water extractable protein per gram
Device Description
HEALTH + AID® PREMIUM Pre-powdered Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves. They are
Ask a Question
Ask a specific question about this device
Page 1 of 1