Gown, Isolation, Surgical

Device Code: 2817

Product Code(s): FYC

Device Classification Information

• Device Type ID: 2817
• Device Name: Gown, Isolation, Surgical
• Regulation Description: Surgical Apparel.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Surgical Devices (DSD); General Surgery Devices Branch One - Light Based/Laser (GSDB1)
• Submission Type: 510(k)
• CFR Regulation Number: 878.4040 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: FYC
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 6-180 ASTM F2407-06 (Reapproved 2013)
  Standard Specification For Surgical Gowns Intended For Use In Healthcare Facilities
• 6-402 ASTM F1670/F1670M-17
  Standard Test Method For Resistance Of Materials Used In Protective Clothing To Penetration By Synthetic Blood
• 14-286 AAMI ANSI ST65:2008/(R)2013
  Processing Of Reusable Surgical Textiles For Use In Health Care Facilities

Total Product Life Cycle

• Device Type ID: 2817
• Device: Gown, Isolation, Surgical
• Product Code: FYC
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Surgical Apparel.
• CFR Regulation Number: 878.4040 [🔎]

Premarket Reviews
Manufacturer	Decision
CARDINAL HEALTH 200, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRIMED MEDICAL PRODUCTS INC.
	SUBSTANTIALLY EQUIVALENT	1

TPLC Last Update: 2019-04-02 20:19:15