Product Classification

• Device: patient examination glove
• Regulation Description: Non-powdered patient examination glove.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: FMC
• Premarket Review: Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B); 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

• 5-62 ASQ ANSI Z1.4-2003 (R2018)
  Sampling Procedures and Tables for Inspection by Attributes

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