Category: Standards & Compliance

Medical gloves are regulated products, and the standards behind them are what make a shipment safe — or stop it at the border. This section explains the key regulatory frameworks for surgical gloves: EN 455 in Europe, FDA 510(k) clearance in the United States, EU MDR certification, and quality systems such as ISO 13485. We break down what each standard actually covers, how they relate to each other, and what documentation buyers and importers should verify before sourcing. If you are new to medical device compliance, start here; if you are experienced, use these guides as a checklist for evaluating suppliers.

Who is the only company in China to get MDR certificate?

Recently, BSI British Standards Institution (British Standards Institution, referred to as: BSI) announced: According to the European Union Medical Device Regulation (MDR, EU 2017/745), Guilin HBM Health Protections Co., Ltd. (hereinafter referred to as “HBM Protections”) issued CE certification of medical device products under the new EU Medical Device Regulation (MDR). The officially certified product is Medispo medical gloves, […]

Guideline surgical gloves registration

When importing surgical gloves, there are dozens of docuements to provided. If it’s first time to import surgical gloves, for example importing Medispo brand, you should register the Medispo brand in the Ministry of Health. The most important thing is the registration documents. As we are in different country, how to ensure documents be approved […]

Guideline Surgical Gloves Registration

Why AQL is So Important in Surgical Gloves,Things You Need To Know

What’s AQL? AQL is abbreviation of Acceptable Quality Level, is an international industry standard sampling process for evaluating the quality of a finished product. AQL measures quality by determining the highest number of defects accepted in a random selection of a product batch. AQL is widely used in the quality inspection of products in various […]

How to identify the surgical gloves FDA certification,things you need to know

The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide a policy […]