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Found 4 results
510(k) Data Aggregation
K Number
K083761Device Name
ALATECH POWDER FREE LATEX EXAMINATION GLOVE
Manufacturer
Date Cleared
2009-07-22
(216 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ALATECH HEALTHCARE, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder free Patient Examination Glove is a disposable device made of natural rubber latex or synthetic material intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner. and as a barrier against potentially infectious materials and other contaminants.
Device Description
A powder free Patient Examination Glove is a disposable device made of natural rubber latex or synthetic material intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner. and as a barrier against potentially infectious materials and other contaminants.
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K Number
K082529Device Name
ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM
Manufacturer
Date Cleared
2009-05-01
(241 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
ALATECH HEALTHCARE, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K080606Device Name
ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE
Manufacturer
Date Cleared
2008-08-07
(156 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ALATECH HEALTHCARE, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powdered Patient Examination Glove is a disposable device made of natural rubber latex or symthetic material that bears powder to facilitate donning and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Device Description
Patient Examination Glove, Powdered (with protein labeling claims claims 300 micrograms or less)
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K Number
K993887Device Name
ALATECH LATEX CONDOM
Manufacturer
Date Cleared
1999-12-20
(34 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
ALATECH HEALTHCARE, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Alatech Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Device Description
Alatech Male Natural Latex Condom
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