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K Number
K171378Device Name
Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs
Manufacturer
SEMPERIT INVESTMENTS ASIA PTE. LTD.
Date Cleared
2017-09-14
(127 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SEMPERIT INVESTMENTS ASIA PTE. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are:
Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes.
Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Cyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Cytarabine (100 mg/ml). Permeation time: no breakthrough up to 240 minutes
Dacarbazine (DTIC) (10.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Doxorubicin Hydrochloride (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Etoposide (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Fluorouracil (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Ifosfamide (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Methotrexate (25.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Mitomycin C (0.5 mg/ml). Permeation time: no breakthrough up to 240 minutes
Mitoxantrone (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Paclitaxel (Taxol) (6.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Thiotepa (10.0 mg/ml). Permeation time: Thiotepa has extremely low permeation times of 13.6 minutes
Vincristine Sulfate (1.0 mg/ml). Permeation time: no Breakthrough up to 240 minutes
DO NOT USE WITH CARMUSTINE OR THIOTEPA
Device Description
The Non-Sterile, Single use, Powder-free Examination glove, Blue, tested for use with Chemotherapy Drugs is provided in blue. It meets all the requirements of ASTM D6319-10. It is a medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves were tested for use with chemotherapy drugs per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug.
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K Number
K160781Device Name
Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves
Manufacturer
SEMPERIT INVESTMENTS ASIA PTE. LTD.
Date Cleared
2017-05-02
(406 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SEMPERIT INVESTMENTS ASIA PTE. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterile Powder Free Synthetic Rubber Gloves is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Sempermed Syntegra IR is a sterile powder-free surgeon glove. It is a disposable device made of synthetic polyisoprene rubber inside coated with synthetic material to ease donning the glove. This glove is intended to be worn on hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
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