Pure Global

Single-use surgical gowns - NMPA Registration 豫械注准20202141133

Access comprehensive regulatory information for Single-use surgical gowns in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 豫械注准20202141133 and owned by SHENGGUANG MEDICAL Instrument Co., Ltd.. The device was approved on July 14, 2022.

This page provides complete registration details including registrant information, province location (Henan), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.

Free Database
Powered by Pure Global AI
NMPA Official Data
Class II
豫械注准20202141133
Single-use surgical gowns
一次性使用手术衣
NMPA Registration Number: 豫械注准20202141133
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

It is worn on the body of surgeons and wiping nurses to prevent the spread of dander on the doctor's body to the open surgical wound and the body fluids of surgical patients to medical staff, playing a two-way biological protection role.

中文

用于穿在手术医生和擦拭护士身上,起到防止医生身体上的皮屑弥散到开放的手术创面和手术病人的体液向医务人员传播,起到双向生物防护的作用。

Device Classification
Device Class
Class II
Model Specifications
Large, medium, small
大号、中号、小号
Registration Information
Registration Number
豫械注准20202141133
Approval Date
July 14, 2022
Expiry Date
June 23, 2025
Registrant
Name
SHENGGUANG MEDICAL Instrument Co., Ltd.
圣光医用制品股份有限公司
Province/Region
Henan
河南
Address
East section of Longshan Avenue, Hao County
郏县龙山大道东段
Production Facility
Production Address
平顶山市郏县龙山大道东段
Structure and Composition
English

This product is made of polypropylene spunbond non-woven fabric or coated non-woven fabric composed of polypropylene and polyethylene as the main raw material, which is cut, sewn or heat-bonded.

中文

本产品由聚丙烯纺粘无纺布或聚丙烯与聚乙烯复合而成的淋膜无纺布为主要原料经裁剪、缝制或热合而成。