Product Classification

• Device: medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs
• Regulation Description: Non-powdered 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 Code: OPJ
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
• Submission Type: 510(k)
• Regulation Number: 880.6250
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 6-496 ASTM F739-20
  Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc