Product Classification

• Device: container, sharps
• Regulation Description: Hypodermic single lumen needle.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: MMK
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
• Submission Type: 510(k)
• Regulation Number: 880.5570
• Device Class: 2
• 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

• 6-215 ASTM F2132-01 (Reapproved 2008)e1
  Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps
• 6-273 ISO 23908 First edition 2011-06-11
  Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
• 6-426 ISO 23907-1 First edition 2019-01
  Sharps injury protection - Requirements and test methods - Sharps containers
• 6-437 ISO 23907-2 First edition 2019-11
  Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers.

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