Search Results
Found 5 results
510(k) Data Aggregation
K Number
K991677Device Name
REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)
Manufacturer
LONDON INTERNATIONAL GROUP, INC.
Date Cleared
2000-04-12
(331 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LONDON INTERNATIONAL GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"An examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner." In addition, the glove is suitable for oncology use.
Device Description
Powder-Free Natural Rubber Latex Examination Glove (Tested For Use With Chemotherapy Drugs) With Protein Content Labeling Claim (50 micrograms or less)
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K Number
K984249Device Name
SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE
Manufacturer
LONDON INTERNATIONAL GROUP, INC.
Date Cleared
1999-05-04
(155 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LONDON INTERNATIONAL GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner.
Device Description
Non-Sterile, Powderfree Nitrile Patient Examination Glove
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K Number
K980942Device Name
REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE
Manufacturer
LONDON INTERNATIONAL GROUP, INC.
Date Cleared
1998-05-11
(60 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
LONDON INTERNATIONAL GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A Sterile surgeon's Glove is worn on the hand of a Surgeon or similar health care person, to prevent contamination between health care providers and the patient during invasive surgical or similar procedures.
Device Description
Sterile Indicator Inner Surgeon's Glove
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K Number
K980516Device Name
REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE
Manufacturer
LONDON INTERNATIONAL GROUP, INC.
Date Cleared
1998-04-23
(72 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
LONDON INTERNATIONAL GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A Sterile surgeon's Glove is worn on the hand of a Surgeon or similar health care person, to prevent contamination between health care providers and the patient during invasive surgical or similar procedures.
Device Description
Sterile Orthopediig,Surgeon's Glove WITH PROTENT UNEUNG CLAIM (50 MICROGRAMS or LESS)
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K Number
K971514Device Name
REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE
Manufacturer
LONDON INTERNATIONAL GROUP, INC.
Date Cleared
1997-10-29
(187 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LONDON INTERNATIONAL GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Non-sterile examination glove
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