Product Classification

• Device: general surgery tray
• Regulation Description: Surgical drape and drape accessories.
• Definition: This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
• Physical State: This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
• Technical Method: This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
• Target Area: This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: LRO
• Premarket Review: General Surgery Devices (DHT4A); General Surgery Devices (DHT4A)
• Submission Type: Enforcement Discretion
• Regulation Number: 878.4370
• 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

• 6-296 AAMI ANSI PB70:2012
  Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
• 6-363 ISO 11810 Second edition 2015-12-15
  Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Primary ignition, penetration, flame spread and secondary ignition
• 6-487 AAMI ANSI PB70:2022
  Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

Third Party Review

Not Third Party Eligible