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510(k) Data Aggregation
K Number
K152692Device Name
Powder Free Vinyl Patient Examination Gloves (Green)
Manufacturer
Date Cleared
2015-12-21
(91 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Supermax Plastic Products Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Powder Free Vinyl Patient Examination Gloves (Green) is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder Free Vinyl Patient Examination Gloves (Green) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2011)--Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.
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K Number
K093797Device Name
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE)
Manufacturer
Date Cleared
2010-02-23
(75 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUPERMAX PLASTIC PRODUCTS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 Classince by I DA's Gelleral Hoopication Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
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K Number
K093798Device Name
POWDER FREE VINYL PATIENT EXAMINATION GLOVE
Manufacturer
Date Cleared
2010-02-23
(75 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUPERMAX PLASTIC PRODUCTS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
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