Search Results
Found 5 results
510(k) Data Aggregation
K Number
K010803Device Name
POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
Manufacturer
Date Cleared
2001-05-11
(56 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HWA TEH INDUSTRIAL SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
K Number
K000725Device Name
HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
Manufacturer
Date Cleared
2000-04-05
(30 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HWA TEH INDUSTRIAL SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
K Number
K994432Device Name
HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
2000-02-16
(48 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HWA TEH INDUSTRIAL SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Device Description
HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS)
Ask a Question
Ask a specific question about this device
K Number
K992810Device Name
HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE
Manufacturer
Date Cleared
1999-09-27
(38 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HWA TEH INDUSTRIAL SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Device Description
Powder-Free Latex Examination Glove
Ask a Question
Ask a specific question about this device
K Number
K992730Device Name
HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE
Manufacturer
Date Cleared
1999-09-14
(32 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HWA TEH INDUSTRIAL SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Device Description
HWA and Silktex Powdered Latex Examination Gloves
Ask a Question
Ask a specific question about this device
Page 1 of 1