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Health & Medical manufacturers in China

China manufactures a large share of the world’s medical consumables and devices: masks and gowns in Hubei (Xiantao), gloves in Shandong and Jiangsu, monitors and ultrasound in Shenzhen, wheelchairs and rehab equipment in Hebei and Zhejiang, dental equipment in Foshan. FDA registration and 510(k) status are the first questions to ask.

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Buying guide: Health & Medical from China

Class I: establishment registration and device listing (most consumables). Class II: 510(k) clearance for the specific device. Ask for the FDA registration number and 510(k) number and verify them in the FDA database; many Chinese suppliers quote “FDA approved” loosely.

ISO 13485 certification is baseline; for US sales the supplier must comply with 21 CFR 820 (QMSR). Request the certificate, latest audit report and a sample DHF/technical file for custom products.

Masks: ASTM F2100 level test reports (BFE, PFE, breathability, fluid resistance); respirators: NIOSH approval (TC number) — KN95 is not NIOSH. Gloves: ASTM D6319 (nitrile) and FDA 510(k) for exam gloves.