Product Classification

• Device: non-surgical gown
• Regulation Description: Surgical apparel.
• Definition: A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material
• Physical State: A gown is made of fabric material, either non-woven or woven
• Technical Method: Serves as physical barrier to the transfer of microorganisms, body fluids and particulate material. Provides minimal or low levels of barrier protection (e.g., ANSI/AAMI PB70 Level 2 or below)
• Target Area: A gown covers the torso and clothing and poses a physical barrier to the transfer of microorganisms, body fluids and particulate material
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General Hospital
• Product Code: OEA
• Premarket Review: Drug Delivery and General Hospital Devices, and Human Factors (DHT3C); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(K) Exempt
• Regulation Number: 878.4040
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible

Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.

If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.

• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 6-474 ASTM F3352-19
  Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
• 6-487 AAMI ANSI PB70:2022
  Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
• 6-488 ASTM F1671/F1671M-22
  Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
• 6-494 ASTM F3352/F3352M-23a
  Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities

Third Party Review

Not Third Party Eligible