일회용 작업복의 미국 수출에 대한 이해(FDA 규정)

The effective design and functionality of disposable coveralls are paramount for ensuring safety in healthcare settings. These garments are engineered to facilitate easy wearing and removal, while their seam areas are meticulously sealed to prevent any form of contamination. Disposable coveralls serve as a critical barrier, shielding healthcare workers from potential sources of infection such as contaminated surfaces, infectious patients’ blood, bodily fluids, secretions, airborne particles, electromagnetic radiation, and hazardous chemicals. This role is crucial in preventing cross-infection within medical facilities and safeguarding the health and safety of doctors, nurses, epidemiologists, pharmacists, and other healthcare professionals.

FDA Classification of Medical Devices

The United States Food and Drug Administration (FDA) categorizes medical devices into three classes based on their risk levels. Class I devices are general products with the lowest risk, Class II devices require special controls for assurance of safety and effectiveness, and Class III devices are those that support or sustain human life, have a potential for unreasonable risk of illness or injury, and are therefore subject to the highest level of regulation.

Types of Disposable Coveralls in the USA

In the U.S., disposable coveralls are divided into non-surgical and surgical categories. Non-surgical disposable coveralls are classified as Class I medical devices, which are exempt from pre-market registration but must be registered with the agency. Surgical disposable coveralls, on the other hand, fall under Class II medical devices, necessitating pre-market registration, specifically an FDA 510(k) application.

The Process for Class II Device Pre-market Notification

The basic steps for Class II product market entry include:

1. Product testing (performance and chemical testing)
2. Preparation of the 510(k) submission
3. Submission for FDA review
4. Receipt of FDA 510(k) clearance
5. Completion of facility registration and device listing
6. Export of the product

Preparing for a 510(k) Submission

Disposable coveralls typically require NIOSH certification to enter the U.S. market and necessitates a 510(k) declaration. This process can be complex, and it is critical for companies to seek advice from consulting agencies with a successful track record in similar product declarations. As demonstrated by Osman’s successful case in disposable coverall 510(k) submissions, not only factory registration and product listing are required, but also a comprehensive 510(k) document. This document includes an application letter, table of contents, FDA samples, registration number, substantial performance equivalence, routine test items, and sterilization functionality.

Compliance Standards: U.S. Performance Testing Standards

The American Society for Testing and Materials (ASTM) published the ASTM F2407-2020 “Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities” in 2020. This specification sets forth requirements for the mechanical, barrier, and other relevant properties of surgical gowns and disposable coveralls used in medical settings.

Barrier performance is evaluated according to the AAMI PB70-2012 revision published by the Association for the Advancement of Medical Instrumentation (AAMI) in 2012. This standard applies to both disposable and reusable surgical gowns and isolation gowns, providing a classification method based on liquid barrier performance and specifying different requirements for each level of disposable coverall.