Product Classification

• Device: container, sharps
• Regulation Description: Hypodermic single lumen needle.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: MMK
• Submission Type: 510(k)
• Regulation Number: 880.5570
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 595-2 First edition 1987-12-15 Reusable all-glass or metal-and-glass syringes for medical use - Part 2: Design, performance requirements and tests
• ISO 23907 First edition 2012-09-01 Sharps injury protection - Requirements and test methods - Sharps containers
• 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
• ASTM F 2132 -01 (Reapproved 2008)e1 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps

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.