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Found 2 results
510(k) Data Aggregation
K Number
K142941Device Name
Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.
Manufacturer
Date Cleared
2015-11-02
(389 days)
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
PT MEDISAFE TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Use with Chemotherapy Drugs; Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color. A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
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K Number
K142190Device Name
Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs
Manufacturer
Date Cleared
2015-07-14
(340 days)
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
PT MEDISAFE TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Polychloroprene Powder-Free Surgical Glove (White) Tested For Use With Chemotherapy Drugs; Polychloroprene Powder-Free Surgical Glove (Green) Tested For Use With Chemotherapy Drugs
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Ask a specific question about this device
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