China’s New Mandatory Standard GB 19082-2023 Now in Force
Mandatory national standard GB 19082-2023 (single-use medical protective clothing) was published on November 27, 2023 and took effect on December 1, 2025, replacing GB 19082-2009. Administered by the National Medical Products Administration, it is the mandatory basis for the registration, manufacturing and inspection of single-use medical protective suits in China.
For hospitals, CDCs and emergency-reserve buyers, this means production and inspection must follow the new standard from its effective date, and acceptance checks should verify the executed standard marked on labels and instructions.
BORUI: Production and Inspection Acceptance Completed Under the New Standard
Beijing Zhongbei Borui Sci-Trade Co., Ltd. (BORUI) has completed the switchover of production and inspection documentation for its single-use medical protective suits to GB 19082-2023, with relevant batches passing factory inspection acceptance, and continues to supply healthcare institutions and reserve programs.
Product highlights (consistent with registration):
- Registration No.: 京械注准 20252140060 (Beijing Medical Products Administration)
- Type: one-piece coverall (with / without foot covers)
- Primary material: composite non-woven fabric
- Sterilization: ethylene oxide (sterile supply)
- Sizes: 160/S — 195/5XL, 8 height sizes
- Production: Class 100,000 cleanroom
The company holds ISO 9001 / ISO 13485 dual certification, is a National High-Tech Enterprise and a Beijing Municipal Pharmaceutical Reserve Unit, and provides complete admission and quality documentation to buyers.
Procurement Notes
Buyers are advised to verify the medical device registration certificate and executed standard, confirm sterilization method and shelf life, and select types and sizes for the intended scenario. BORUI supports sample confirmation and volume supply programs.
Procurement inquiries: 010-56467560 | info@zbbj.cn, or via the Contact page on our website.