Recently, the Market Supervision Bureau of Taishan District in Tai'an City, Shandong Province, carried out supervisory inspections targeting manufacturers of Class I medical devices, specifically protective gear, within its jurisdiction. The inspection focused on products such as medical fixation belts, medical waist supports, and medical knee braces. Key areas of scrutiny included compliance with filing requirements, raw material control, production processes, quality testing, and product labeling and instructions. Methods such as on-site verification, record reviews, workshop inspections, and physical product comparisons were employed to comprehensively identify potential quality and safety risks. Enforcement officers prioritized verifying the authenticity and validity of manufacturers' Class I medical device production and product filings, ensuring that production conditions consistently met filing standards. They also assessed whether raw material procurement, acceptance procedures, and supplier management adhered to regulations, and whether production workflows and quality control records were complete and traceable. Additionally, inspectors confirmed that product labels and instructions matched the filed content, strictly prohibiting violations such as manufacturing beyond authorized scope, false labeling, or exaggerated indications for use. Alongside the inspection, regulatory guidance was provided to help companies strictly implement requirements under the Medical Device Supervision and Administration Regulations and the Medical Device Production Quality Management规范, aiming to improve quality control systems and enhance compliance in production. Moving forward, the Taishan District Market Supervision Bureau will continue to strengthen full-chain oversight of Class I medical devices, regularly conducting post-filing verifications and follow-up reviews. Through rigorous standards and practical measures, the bureau aims to safeguard the quality and safety of protective gear products, thereby protecting public health.