ProMax Surgical Gown

Basic Information

• Brand Name: ProMax Surgical Gown
• Primary DI: 00634916819038
• Version / Model: 75615074
• Company Name: STANDARD TEXTILE CO., INC.
• Labeler DUNS: 006999858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2021-06-11
• Public Version: 1
• Public Version Date: 2021-06-21
• Public Version Status: New
• Public Device Record Key: e016be9a-9f0d-4526-a545-eb09354a137f

Device Description

ProMax Surgical Gown, MLR Front Yoke with Kaumograph, Comfort Panel Back with Negastat, Color Coded Neck Binding, Snap Closures at Neck, Color Coded Tie Closures at Waist, With QCM, Size XL

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FYA	Gown, Surgical	General, Plastic Surgery	878.4040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11902	Surgical gown, reusable	A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a reusable garment intended to be laundered after each use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10634916819035	GS1
Primary	00634916819038	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K041540	000