Search Results
Found 25 results
510(k) Data Aggregation
K Number
K170779Device Name
Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein
Manufacturer
Terang Nusa Sdn Bhd
Date Cleared
2017-05-24
(70 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Terang Nusa Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nugard Black Powder Free Latex Examination Glove is a disposable device and is made of natural rubber latex intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein
Ask a Question
K Number
K161932Device Name
Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink
Manufacturer
Terang Nusa Sdn Bhd
Date Cleared
2016-11-28
(137 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Terang Nusa Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Powder Free Polychloroprene Examination Glove Blue or Pink, non sterile is a disposable device and is made of synthetic rubber intended for medial purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder Free Polychloroprene Examination Glove Blue Powder Free Polychloroprene Examination Glove Pink
Ask a Question
K Number
K153510Device Name
Powder Free Polychloroprene Examination Glove Green
Manufacturer
TERANG NUSA SDN BHD
Date Cleared
2016-03-21
(105 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TERANG NUSA SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Powder Free Polychloroprene Examination Glove Green, Non Sterile is a disposable device and is made of synthetic rubber intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
The Powder Free Polychloroprene Examination Glove Green, Non Sterile is a disposable device and is made of synthetic rubber intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Ask a Question
K Number
K151392Device Name
Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less
Manufacturer
TERANG NUSA SDN BHD
Date Cleared
2015-09-18
(115 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
TERANG NUSA SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The surgeon's gloves 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
SENSIFLEX PLUS Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less
Ask a Question
K Number
K140355Device Name
SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM
Manufacturer
TERANG NUSA SDN BHD
Date Cleared
2014-11-06
(267 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
TERANG NUSA SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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. The lubricating or dusting powder used in the glove is excluded. (as per described in 21 CFR 878,4460)
Device Description
SENSIFLEX PLUS Sterile Latex Surgical Gloves Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less
Ask a Question
K Number
K110698Device Name
NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE
Manufacturer
TERANG NUSA SDN BHD
Date Cleared
2011-12-07
(293 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
TERANG NUSA SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Surgeons Glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded. These gloves are tested for use with Chemotherapy Drugs.
Device Description
Polychloroprene Synthetic Tan Surgical gloves Powder Free
Ask a Question
K Number
K102230Device Name
NUGARD NITILE GREY COLOR
Manufacturer
TERANG NUSA SDN BHD
Date Cleared
2010-09-10
(32 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TERANG NUSA SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A Non-Sterile Nitrile powder free examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Nitrile Examination Gloves Powder Free Grey Color Non-Sterile
Ask a Question
K Number
K102119Device Name
SUR-G GLOV AND MAXITEX
Manufacturer
TERANG NUSA SDN BHD
Date Cleared
2010-08-27
(30 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
TERANG NUSA SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The surgeon's gloves are sterile gloves to be worn by surqeons, healthcare workers or similar personnel during surgical procedures to prevent contamination between the user and the patient.
Device Description
Latex Surgical Gloves Powdered, Sterile.
Ask a Question
K Number
K083337Device Name
NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES
Manufacturer
TERANG NUSA SDN BHD
Date Cleared
2009-01-27
(76 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TERANG NUSA SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K052837Device Name
SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA
Manufacturer
TERANG NUSA SDN BHD
Date Cleared
2005-11-21
(46 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
TERANG NUSA SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Surgeon's glove is a device made of natural rubber intended to be worn by This Surgeon's glove to a so notect a surgical wound from contamination.
Device Description
Sensiflex Plus, Polymer Coated Latex Surgical Glove Powder Free, Sterile, Coated with Aloe Vera, contains 50 micrograms or less of total water extractable protein per gram.
Ask a Question
Page 1 of 3