Examples of product names: surgical gowns, single-use sterile surgical gowns Classification code and classification: 14-13-05, Class II instruments.
Surgical gowns are divided into two supply forms: sterile to provide single-use and non-sterile to provide reusable. Surgical gowns are divided into standard and high performance types according to the barrier capacity of the critical area.
Scope of application: Used to wear on surgeons and scrub nurses to play a role in preventing the diffusion of dander from the surgeon's body to the open surgical wound and the transmission of body fluids from the surgical patient to the medical staff, playing a two-way biological protection role.
Intended use: Single-use surgical gowns are used to prevent the transmission of infectious agents between patients and medical personnel during surgical procedures and other invasive examinations; among them, high-performance surgical gowns are suitable for surgeries in which the infectious virus is known to be present in the patient's blood or in which it is unknown whether the infectious virus is present in the blood during emergency resuscitation; standard performance surgical gowns are suitable for surgeries in which the infectious virus is known not to be present in the patient's blood.
Single-use sterile surgical gowns and reusable non-sterile surgical gowns do not belong to the same registration unit and should be registered separately for declaration.
Surgical gown products belong to the catalog of medical devices exempt from clinical trials, can be exempt from clinical trials, only need to submit clinical evaluation information.