Search Results
Found 5 results
510(k) Data Aggregation
K Number
K021598Device Name
ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE
Manufacturer
Date Cleared
2002-06-10
(26 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ECI MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powdered surgeon's glove is a disposable device made of synthetic-co-polymer that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Device Description
A powdered surgeon's glove is a disposable device made of synthetic-co-polymer that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Ask a Question
Ask a specific question about this device
K Number
K020918Device Name
ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE
Manufacturer
Date Cleared
2002-04-19
(29 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ECI MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder-free surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Device Description
Elastyfree™ Synthetic Powder-Free Surgical Glove
Ask a Question
Ask a specific question about this device
K Number
K984337Device Name
ELASTYLON POWDER-FREE SURGICAL GLOVE
Manufacturer
Date Cleared
1999-04-09
(127 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ECI MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A surgical glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Elastylon ® Powder-Free Surgical Glove
Ask a Question
Ask a specific question about this device
K Number
K971471Device Name
ELASTYREN POWDER-FREE SURGICAL GLOVE
Manufacturer
Date Cleared
1998-02-09
(292 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ECI MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A surgeon's glove is a device made of natural or systemic rubber insended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Elastyren Powder-Free Surgical Glove
Ask a Question
Ask a specific question about this device
K Number
K970015Device Name
ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
1997-06-24
(173 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ECI MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient 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
Elastyren Powder-Free Patient Examination Gloves
Ask a Question
Ask a specific question about this device
Page 1 of 1