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510(k) Data Aggregation
K Number
K161929Device Name
Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove
Manufacturer
Date Cleared
2017-03-29
(258 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Dipped Products (Thailand) Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Palm-pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove has also been tested for use with Chemotherapy Drugs.
The following Chemotherapy drugs have been tested for use with these gloves in accordance with ASTM D6978-05:
Chemotherapy drug (concentration) | Breakthrough Detection Time
-----------------------------------|-----------------------------------
Dacarbazine (10,000 ppm) | No breakthrough up to 240 minutes
*Carmustine (BCNU) (3,300 ppm) | Breakthrough at 30.6 minutes
Cyclophosphamide (20,000 ppm) | No breakthrough up to 240 minutes
Doxorubicin Hydrochloride (2,000 ppm) | No breakthrough up to 240 minutes
Fluorrouracil (5,000 ppm) | No breakthrough up to 240 minutes
Cisplatin (1,000 ppm) | No breakthrough up to 240 minutes
Etoposide (20,000 ppm) | No breakthrough up to 240 minutes
Paclitaxel (6,000 ppm) | No breakthrough up to 240 minutes
Thiotepa (10,000 ppm) | Breakthrough at 181.3 minutes
*Please note that the following drug has extremely low permeation times: Carmustine (BCNU): 30.6 minutes.
Device Description
The Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs are patient examination gloves that worn by an examiner to prevent contamination between the patient and examiner. The gloves are suitable for use with Chemotherapy drugs, are ambidextrous and green in color. The gloves are supplied non-sterile, in boxes of 100 (measured by weight), intended for single use and are disposable.
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