FDA guidance defines gown classifications and performance standards under ANSI/AAMI PB70 for surgical and medical protective apparel.

FDA guidelines define ANSI/AAMI PB70 compliance, barrier testing, and labeling requirements to classify gowns as Class II medical devices.

Surgical drapes maintain a sterile field, prevent contamination, and ensure infection control across various surgical procedures.

Effective infection control in surgery relies on sterilization, wound care, and post-surgical precautions to prevent surgical site infections.

Surgeine Healthcare offers sterile urological drapes designed to manage high fluid volumes and maintain a sterile field during urology procedures. 

Surgical drape standards from the Association of Surgical Technologies (AST) address sterility, material quality, and handling procedures that help minimize contamination and reduce the risk of Surgical Site Infections.