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Found 4 results
510(k) Data Aggregation
K Number
K012880Device Name
STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
2001-11-16
(80 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SSN GLOVES (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Sterile Powder Free Latex Surgical Gloves with Protein Labeling Claim ( 50 micrograms or less )
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K Number
K012896Device Name
STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
2001-11-16
(80 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SSN GLOVES (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim ( 200 Micrograms or Less )
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K Number
K990526Device Name
KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
Manufacturer
Date Cleared
1999-04-23
(63 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SSN GLOVES (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A MEDICAL OR A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE WORN ON THE HAND OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.
Device Description
Kleenhands Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)
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K Number
K990527Device Name
KLEENHANDS POWDERED LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
1999-04-23
(63 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SSN GLOVES (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A MEDICAL OR A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE WORN QU THE HAND OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN THE HEALTH CARE PERSONNEL AND THE PATIENT.
Device Description
Kleenhands Powdered Latex Examination Gloves
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Ask a specific question about this device
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