Search Results
Found 4 results
510(k) Data Aggregation
K Number
K014283Device Name
LATEX SURGEONS GLOVE (POWDER FREE)
Manufacturer
Date Cleared
2002-05-22
(146 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
BRIGHTWAY GLOVES PVT. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder free Surgeon's glove is a sterile powder free medical device intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Class I Powder free Surgical Glove 79KGO that meets all 'the requirements of ASTM D3577.
Ask a Question
Ask a specific question about this device
K Number
K014278Device Name
LATEX SURGEONS GLOVE (POWDERED)
Manufacturer
Date Cleared
2002-05-14
(138 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
BRIGHTWAY GLOVES PVT. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Surgeon's glove (powdered) is a sterile medical device made of natural latex intended to be worn by operating room personnel to protect a surgical wound from contamination and is powdered with absorbable dusting powder USP corn starch as the donning lubricant.
Device Description
Class I Powdered Surgical Glove 79KGO that meets all the requirements of ASTM D3577.
Ask a Question
Ask a specific question about this device
K Number
K014279Device Name
LATEX EXAMINATION GLOVES (POWDER FREE)
Manufacturer
Date Cleared
2002-03-20
(83 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BRIGHTWAY GLOVES PVT. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
EXAMINATION GLOVES POWDER FREE IS A POWDER FREE LATEX DISPOSABLE DEVICE MADE OF NATURAL RUBBER LATEX INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINERS HAND ob eximali contrail contrainer time between batten and EXAMINER.
Device Description
Class I Patient Examination Gloves Latex (Powder free) 80L Y Y that meets all the requirements of ASTM D3578
Ask a Question
Ask a specific question about this device
K Number
K014280Device Name
LATEX EXAMINATION GLOVE (POWDERED)
Manufacturer
Date Cleared
2002-03-20
(83 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BRIGHTWAY GLOVES PVT. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
EXAMINATION GLOVE (POWDERED) IS A DISPOSABLE DEVICE MADE OF NATURAL LATEX INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINERS HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER AND IS POWDERED WITH A DONNING POWDER ABSORBABLE USP CORN STARCH.
Device Description
Class I Patient Examination Gloves (powdered) 80L that meets all 'the requirements of ASTM D3578.
Ask a Question
Ask a specific question about this device
Page 1 of 1