Product Classification

• Device: finger cot
• Regulation Description: Patient examination glove.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: LZB
• Submission Type: 510(k)
• Regulation Number: 880.6250
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ASTM D3772-01 (Reapproved 2010) Standard Specification for Natural Rubber Finger Cots
• ASTM D6499-12 Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products
• ASTM D6355-07 Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
• ASTM D7103-06 (E 2010) Standard Guide for Assessment of Medical Gloves

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• pharmalink technical group, llc
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.