Search Results
Found 3 results
510(k) Data Aggregation
K Number
K101351Device Name
NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT
Manufacturer
Date Cleared
2010-10-15
(154 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ASCEND EAGLE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
These Non-Sterile, Powder-Free Peach Color, Nitrile Examination Gloves with Lano-E and Peppermint Citrus Scent, are a disposable (single-use-only) device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Non-Sterile, Powder-Free PEACH Color, Nitrile Examination Gloves with Lano-E and Peppermint Citrus Scent
Ask a Question
Ask a specific question about this device
K Number
K092472Device Name
NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES, WITH OR WITHOUT CITRUS/ PEPPERMINT SCENT
Manufacturer
Date Cleared
2010-04-15
(246 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ASCEND EAGLE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
These Non-Sterile, Powder-Free, AQUA NITRILE Examination Gloves with Lano-E and Peppermint Citrus Scent, are a disposable (single-use-only) device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Non-Sterile, Powder Free, AOUA NITRILE Examination Gloves with Lano- E and Peppermint Citrus Scent
Ask a Question
Ask a specific question about this device
K Number
K052666Device Name
NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR WIHOUT CITRUS/PEPPERMINT SCENT PLUS A PROTEIN
Manufacturer
Date Cleared
2006-01-25
(120 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ASCEND EAGLE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Non-Sterile, Powder-Free, Latex Examination Gloves, with Lanolin and Vitamin E Coating, Natural or Green Colonese &acmination (Hores, With Lanoin and Vitamin F and with Protein Labelian Claim (Combined Citrus-Peppermint), 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 examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Non-Sterile Powder-Free Natural/Green Lano-E Latex Exam Gloves, with or without Citrus/Peppermint scent plus a protein labeling claim. (Multiple Private Labels) Common Name: Latex Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM Standard D 3578-01aE2.
Ask a Question
Ask a specific question about this device
Page 1 of 1