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U.S. Department of Health and Human Services

Product Classification

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Device medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs
Regulation Description Patient examination glove.
Definition A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner.In addition, these gloves have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using test such as astm d6978-05, standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs.
Physical State A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using test such as ASTM D6978-05, Standard Practice for Assessment of Resistance of medical Gloves to Permeation by Chemotherapy Drugs.
Technical Method A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using test such as ASTM D6978-05, Standard Practice for Assessment of Resistance of medical Gloves to Permeation by Chemotherapy Drugs.
Target Area Glove
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeOPJ
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Infection Control Devices Branch (INCB)
Submission Type 510(k)
Regulation Number 880.6250
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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