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Found 6 results
510(k) Data Aggregation
K Number
K172420Device Name
Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
Manufacturer
Wear Safe (Malaysia) Sdn. Bhd.
Date Cleared
2017-09-29
(50 days)
Product Code
KGO, LZC
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Wear Safe (Malaysia) Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloyes were tested for use with cherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
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K Number
K101799Device Name
POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE
Manufacturer
WEAR SAFE (MALAYSIA) SDN. BHD.
Date Cleared
2010-09-03
(67 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WEAR SAFE (MALAYSIA) SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder free latex examination glove is a disposable device made of natural rubber material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants.
Device Description
Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile will meet all the current specification for ASTM D3578.
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K Number
K093500Device Name
POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE
Manufacturer
WEAR SAFE (MALAYSIA) SDN. BHD.
Date Cleared
2010-01-19
(68 days)
Product Code
LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WEAR SAFE (MALAYSIA) SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder free nitrile examination glove is a disposable device made of synthetic material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants. In addition, this product is tested for use with chemotherapy drugs.
Device Description
Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non Sterile (Chemotherapy Drug Protection Labeling Claim) will meet all the current specification for ASTM D6319.
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K Number
K092492Device Name
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O
Manufacturer
WEAR SAFE (MALAYSIA) SDN. BHD.
Date Cleared
2009-10-21
(69 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WEAR SAFE (MALAYSIA) SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder free polymer coated latex examination glove is a disposable device made of natural rubber material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants.
Device Description
The Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein will meet all the current specification for ASTM D3578.
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K Number
K090066Device Name
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE
Manufacturer
WEAR SAFE (MALAYSIA) SDN. BHD.
Date Cleared
2009-05-15
(126 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
WEAR SAFE (MALAYSIA) SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder free polymer coated latex surgical glove is a disposable device made of natural rubber material intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
The Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein will meet all the current specification for ASTM D3577.
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K Number
K090327Device Name
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE
Manufacturer
WEAR SAFE (MALAYSIA) SDN. BHD.
Date Cleared
2009-04-03
(53 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WEAR SAFE (MALAYSIA) SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder free polymer coated latex examination glove is a disposable device made of natural rubber material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants.
Device Description
The Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm- of glove or less of water soluble protein will meet all the current specification for ASTM D3578.
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