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510(k) Data Aggregation
K Number
K112005Device Name
NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
2012-03-21
(252 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
UG HEALTHCARE (USA), INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Device Description
Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim
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K Number
K112012Device Name
NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES
Manufacturer
Date Cleared
2012-03-21
(252 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
UG HEALTHCARE (USA), INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Device Description
Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue. A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and the examiner.
Summary of Technological Characteristics:
Cuff: Beaded
Material: Nitrile
Powder Residue: Maximum 2mg/glove
Quality Assurance: In compliance with ASTM D6319-10, ISO 2859-1, manufactured under ISO9001:2008 and ISO 13485:2003
Physical Properties:
Overall Length: 240 mm minimum
Width: 95 mm minimum (for medium glove)
Thickness: .05 mm minimum
BEFORE AGING: Tensile Strength: 14.0 Mpa minimum, Ultimate Elongation: 500% minimum
AFTER AGING: Tensile Strength: 14.0 Mpa minimum, Ultimate Elongation: 400% minimum
Special Properties: None
Packaging: 150 pcs per dispenser box, 10 boxes per case, 1,500 gloves per case
Sizes: XS — XL
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K Number
K062688Device Name
POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
Manufacturer
Date Cleared
2006-11-30
(83 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
UG HEALTHCARE (USA), INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Powder-Free Black Examination Glove with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Device Description
Trade Name: Powder-Free Black Latex Examination Glove With Protein Labeling Claim
Common Name: Examination Gloves
Classification Name: Patient Examination Glove (per 21 CFR 880.6251)
Class 1: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM D3578-05.
Powder Residue: Maximum 2mg/glove
Cuff: Beaded
Material: Latex Material. Latex Quality ASSurancer 11: Com859-1:1999 and manufactured under ISO9001:2000
Overall Length: 240 mm minimum
Width: 95 mm minimum (for medium glove)
Palm Thickness: 0.13 to 0.18mm (at center of palm)
Finger Thickness: 0.15 to 0.20 mm (at 15mm from tip of center finger)
Cuff Thickness: 0.10 to 0.15 mm (at 40mm from the beaded end)
BEFORE AGING Tensile Strength: 21.0 Mpa minimum
BEFORE AGING Ultimate Elongation: 700% minimum
BEFORE AGING Pinhole AQL 1.5 minimum
AFTER AGING 16.0 Mpa minimum
AFTER AGING 500% minimum
AFTER AGING 1.5 minimum
Special Properties: Black Colorant
Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case
Sizes: XXS — XXL
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