Search Results
Found 3 results
510(k) Data Aggregation
K Number
K222129Device Name
Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
Manufacturer
Date Cleared
2023-02-10
(207 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Top Glove Medical (Thailand) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
An examination glove is a disposable glove intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
Ask a Question
Ask a specific question about this device
K Number
K022016Device Name
POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE
Manufacturer
Date Cleared
2002-10-15
(117 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP GLOVE MEDICAL (THAILAND) CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The glove is disposable and intended for Medical purpose that is worn on the hand to prevent contamination between the patient and the examiner.
Device Description
Polymer Coated Powderfree Latex Examination Gloves
Ask a Question
Ask a specific question about this device
K Number
K021950Device Name
TOP GLOVE MEDICAL (THAILAND) POWDERED LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2002-08-01
(49 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP GLOVE MEDICAL (THAILAND) CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powdered Latex Examination Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
Page 1 of 1