Product Classification

• Device: medical glove, specialty
• Definition: A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: LZC
• Premarket Review: Infection Control and Plastic Surgery Devices (DHT4B); Infection Control and Plastic 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 Standards

• 6-214 ASTM D6355-07(2022)
  Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
• 6-354 ASTM D7907-14 (Reapproved 2019)
  Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves
• 6-411 ASTM D6499-18
  Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
• 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
• sgs north america
• third party review group, llc