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Found 6 results
510(k) Data Aggregation
K Number
K001715Device Name
POWDERED PATIENT EXAMINATION GLOVES, LATEX
Manufacturer
Date Cleared
2000-07-05
(30 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
FITCO DIPPED PRODUCTS PVT. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K001232Device Name
NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS
Manufacturer
Date Cleared
2000-05-15
(28 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
FITCO DIPPED PRODUCTS PVT. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K000896Device Name
POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS
Manufacturer
Date Cleared
2000-05-03
(44 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
FITCO DIPPED PRODUCTS PVT. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K000891Device Name
STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
2000-04-28
(39 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
FITCO DIPPED PRODUCTS PVT. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K001216Device Name
POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
2000-04-28
(14 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
FITCO DIPPED PRODUCTS PVT. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K993450Device Name
LATEX SURGICAL GLOVES, PRE-POWDERED
Manufacturer
Date Cleared
1999-12-29
(78 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
FITCO DIPPED PRODUCTS PVT. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This Surgeon's Glove is a device made of natural rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination. Surface powder should be removed prior to undertaking operative procedures in order to minimise the risk of adverse tissue reaction. Contents sterile until package is opened or damaged.
Device Description
Class 1, 21 CFR 878.4460. Latex Surgical Gloves, 79 KGO and meets all requirements of ASTM standard D-3577-91.
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