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510(k) Data Aggregation
K Number
K240266Device Name
Latex Examination Glove Powder Free (Ocean Blue and Natural White)
Manufacturer
Sri Trang Gloves (Thailand) Public Company Limited
Date Cleared
2024-09-09
(222 days)
Product Code
LYY, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Sri Trang Gloves (Thailand) Public Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs and permeation times are as follows:
Bleomycin Sulfate 15 mg/mL, >240 minutes
Busulfan 6 mg/mL, >240 minutes
Carboplatin (Paraplatin) 10 mg/mL, >240 minutes
Carmustine (BCNU) 3.3 mg/mL, 1.9 minutes
Cisplatin 1.0 mg/mL, >240 minutes
Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes
Cytarabine HC1 100 mg/mL, >240 minutes
Dacarbazine (DTIC) 10 mg/mL, >240 minutes
Daunorubicin HC1 5 mg/mL, >240 minutes
Docetaxel 20 mg/mL, >240 minutes
Doxorubicin Hydrochloride 2 mg/mL, >240 minutes
Epirubicin HC1 (Ellence) 2 mg/mL, >240 minutes
Etoposide (Toposar) 20 mg/mL, >240 minutes
Fludarabine 25 mg/mL, >240 minutes
Fluorouracil 50 mg/mL, >240 minutes
Gemcitabine 38 mg/mL, >240 minutes
Idarubicin HCl 1 mg/mL, >240 minutes
lfosfamide 50 mg/mL, >240 minutes
Irinotecan 20 mg/mL, >240 minutes
Mechlorethamine HC1 1 mg/mL, >240 minutes
Melphalan 5 mg/mL, >240 minutes
Methotrexate 25 mg/mL, >240 minutes
Mitomycin C 0.5 mg/mL, >240 minutes
Mitoxantrone 2 mg/mL, >240 minutes
Paclitaxel (Taxol) 6 mg/mL, >240 minutes
Rituximab 10 mg/mL, >240 minutes
Thiotepa 10 mg/mL, 3.7 minutes
Trisenox 1 mg/mL . >240 minutes
Vincristine Sulfate 1 mg/mL, >240 minutes
Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL, >240 minutes
WARNING: Not for use with Carmustine or Thiotepa.
Device Description
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
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K Number
K232614Device Name
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)
Manufacturer
Sri Trang Gloves (Thailand) Public Company Limited
Date Cleared
2024-05-13
(259 days)
Product Code
LZA, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Sri Trang Gloves (Thailand) Public Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs are as follows: Carmustine (BCNU) 3.3 mg/mL, 23 minutes Cisplatin 1.0 mg/mL. >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Dacarbazine (DTIC) 10.0 mg/mL, >240 minutes Doxorubicin 2.0 mg/mL. >240 minutes Etoposide (Toposar) 20.0 mg/mL, >240 minutes Fluorouracil 50.0 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes Paclitaxel (Taxol) 6.0 mg/mL, >240 minutes Thiotepa 10.0 mg/mL, 68.2 minutes Vincristine Sulfate 1.0 mg/mL, >240 minutes
WARNING: Not for use with Carmustine and Thiotepa.
Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL, >240 minutes
Device Description
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Violet Blue)
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K Number
K221165Device Name
Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl
Manufacturer
Sri Trang Gloves (Thailand) Public Company Limited
Date Cleared
2022-11-20
(212 days)
Product Code
LZA, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Sri Trang Gloves (Thailand) Public Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THIS DEVICE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PROPOSE THAI IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Device Description
Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl
Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl
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K Number
K212482Device Name
Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
Manufacturer
Sri Trang Gloves (Thailand) Public Company Limited
Date Cleared
2022-08-09
(365 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Sri Trang Gloves (Thailand) Public Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
CAUTION: Safe use of this glove by on or latex sensitized individuals has not been established. CAUTION: This product contains natural rubber latex which may cause allergic reactions.
Device Description
Non-Sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
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K Number
K212309Device Name
Non-sterile, Powder-Free Latex Examination Glove
Manufacturer
Sri Trang Gloves (Thailand) Public Company Limited
Date Cleared
2022-04-08
(259 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Sri Trang Gloves (Thailand) Public Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This glove contains 50 micrograms or less of total water extractable protein per gram.
CAUTION: Safe use of this glove by or on latex sensitized individuals has not been established. CAUTION: This product contains natural rubber latex which may cause allergic reactions
Device Description
Non-sterile, Powder-Free Latex Examination Glove
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K Number
K200539Device Name
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl
Manufacturer
Sri Trang Gloves (Thailand) Public Company Limited
Date Cleared
2020-04-09
(37 days)
Product Code
LZA, LZC, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Sri Trang Gloves (Thailand) Public Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs and permeation times are as follows: Carmustine (BCNU) 3.3 mg/mL, 11.6 minutes Cisplatin 1.0 mg/mL, >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Dacarbazine (DTIC) 10.0 mg/mL, >240 minutes Doxorubicin 2.0 mg/mL. >240 minutes Etoposide (Toposar) 20.0 mg/mL, >240 minutes Fluorouracil 50.0 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes Paclitaxel (Taxol) 6.0 mg/mL, >240 minutes Thiotepa 10.0 mg/mL, 36.2 minutes Vincristine Sulfate 1.0 mg/mL. >240 minutes WARNING: Not for use with Carmustine and Thiotepa.
Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL, >240 minutes
Device Description
Non-sterile, Powder-Pree Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl
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K Number
K193581Device Name
Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster
Manufacturer
Sri Trang Gloves (Thailand) Public Company Limited
Date Cleared
2020-03-20
(88 days)
Product Code
LZA, LZC, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Sri Trang Gloves (Thailand) Public Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs and permeation times are as follows:
Bleomycin Sulfate 15 mg/mL, >240 minutes Busulfan 6 mg/mL. >240 minutes Carboplatin (Paraplatin) 10 mg/mL, >240 minutes Carmustine (BCNU) 3.3 mg/mL, 17.1 minutes Cisplatin 1.0 mg/mL, >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Cytarabine 100 mg/mL, >240 minutes Dacarbazine (DTIC) 10 mg/mL, >240 minutes Daunorubicin 5 mg/mL, >240 minutes Docetaxel 10 mg/mL, >240 minutes Doxorubicin Hydrochloride 2 mg/mL, >240 minutes Epirubicin (Ellence) 2 mg/mL. >240 minutes Etoposide (Toposar) 20 mg/mL, >240 minutes Fludarabine 25 mg/mL, >240 minutes Fluorouracil 50 mg/mL, >240 minutes Gemcitabine 38 mg/mL, >240 minutes Idarubicin 1 mg/mL, >240 minutes
Ifosfamide 50 mg/mL, >240 minutes Irinotecan 20 mg/mL, >240 minutes Mechlorethamine 1 mg/mL, >240 minutes Melphalan 5 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes Mitomycin C 0.5 mg/mL, >240 minutes Mitoxantrone 2 mg/mL, >240 minutes Paclitaxel (Taxol) 6 mg/mL, >240 minutes Rituximab 10 mg/mL, >240 minutes Thiotepa 10 mg/mL, 27.9 minutes Trisenox 1 mg/mL , >240 minutes Vincristine Sulfate 1 mg/mL, >240 minutes
Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL. >240 minutes
WARNING: Not for use with Carmustine or Thiotepa.
Device Description
Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs and Fentanyl.
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