Contact Us

Method for Distinguishing Disposable Medical Gowns from Non-medical Gowns

1. Packaging Information

Observe whether there are words such as "medical" or "surgical" on the product packaging information. Observe whether product packaging information describes medical application scenarios and medical uses. If there is relevant information, it is medical gown.

2. Applicable Standards

There are different standards and certification requirements for medical gowns in different countries and regions. Enterprises and individuals can distinguish them according to the applicable standards of products. The applicable standards and certification information of products can be obtained from the outer packaging of products and the test reports or certificates provided by producers.

(1) Chinese Related Standards

China has a special standard for disposable medical gowns: GB19082-2009 Technical Requirements for Single-Use Protective Clothing for Medical Use. As long as the implementation standard is marked as GB19082, it is medical gown.

(2) Relevant EU Standards

The medical gowns of EU are applicable to the medical device regulation 93/42/EEC, which will be replaced by the new EU medical device regulation EU2017/745(MDR) on May 26th, 2020. However, on March 25th, the European Commission announced a proposal to postpone the implementation of MDR regulations for one year, which was submitted in early April for adoption by the European Parliament and Council before the end of May. This proposal puts forward additional and different requirements. Non-medical personal protective equipment in EU is applicable to Personal Protective Equipment (PPE) Regulation, namely EU2016/425. Protective clothing exported to EU should refer to CE certificate. There is corresponding medical device regulation 93/42/EEC or EU2017/745 directive on CE certificate. If the organization is indeed authorized by 93/42/EEC or EU2017/745 through CE certificate inquiry, then their products are medical gowns.


Contact Us

Thanks for your inquiry! We will respond within 24 hours.