Product Classification

• Device: powder, dusting, surgical
• Regulation Description: Absorbable powder for lubricating a surgeon's glove.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: KGP
• Submission Type: PMA
• Regulation Number: 878.4480
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• CLSI I/LA20-A2 Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; Approved Guideline - Second Edition

Guidance Document

• Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon’s Glove - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible