Product Classification

• Device: powder-free non-natural rubber latex surgeon's gloves
• Definition: A powder-free surgeon's glove is a disposable device made of non-natural rubber that may bear a trace amount of residual powder and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
• Physical State: A powder-free surgeon's glove is a disposable device made of non-natural rubber that may bear a trace amount of residual powder and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
• Technical Method: A powder-free surgeon's glove is a disposable device made of non-natural rubber that may bear a trace amount of residual powder and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
• Target Area: glove
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General Hospital
• Product Code: OPA
• Premarket Review: Infection Control and Plastic Surgery Devices (DHT4B); Infection Control and Plastic Surgery Devices (DHT4B)
• Submission Type: 510(k)
• Regulation Number: 878.4460
• 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

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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