Views: 0 Author: Site Editor Publish Time: 2023-12-07 Origin: Site
1 Introduction of the company
Medtrue Enterprise Co., Ltd. is a specialized OEM of medical and health care products, adhering to the principle of ‘Professional takes you to satisfaction’. We apply ourselves to offer better service to customers with our abundant experience since 1994 in this market, under the system ISO13485:2003.
Specifically, the main products include hospital equipment, medical instruments, health & home care products, medical disposable products, surgical dressings, laboratory products, education products, pharmaceutical materials and chemical products.
Excellent Service, Competitive Prices and Prompt Delivery, we are now looking forward to even greater cooperation with overseas customers based on mutual benefits. Please feel free to contact us for more information.
The OEMs of our company have all passed CE attestation. The quality and production management of the product meet with ISO13485 medical device quality management system, MDD93/42/EEC and the requirements of Europe harmony standard.
2 Brief Introduction
2.1 General Information
The material is PP non-woven, the materials have many good properties, such as soft, clean, good filtration and uniformity and waterproof, they are not sensitive to human beings, difficult to fluff, they don't have any peculiar smell, other matters and primary colour. In a word, they are desirable sanitation material. The surgical gowns by using the materials have properties such as:
1) They have enough strength and good waterproof. They offer a credible barrier for medical personnel and can effectively block liquid splash which is often taken place in operation.
2) They have low rate of falling crumbs, do not have noise in abrasion and don't glisten in lamp, and is easy to sterilize; they can be decomposed and don't have any pollution to environment.
3) The materials offer safety and comfort for doctor and nurse because of softness and waterproof. In the meantime, because the surgical gowns have good performance of water-resist and liquid-separate, the oozy liquid in operation can be effectively obstructed to prevent the bacteria infection.
2.2 Product Picture
2.3 Model: MT59057001～MT59057012
Statement: Our Product is consistency with OEM Product except the label. And the labels see MT/CE 46-06 <Label and Language>.
3 Intended Use
Disposable Surgical Gowns are especially designed for the medical personnel using in operation. The medical personnel are dressed with them in operation so that the blood, body fluid and exudation of patients, which has potential infection, can be obstructed effectively to prevent the bacteria infection.
4 Flow chart of production processes see “MT/CE 46 Annex 2”.
5 Cautions
a) The product can be used only once, it should be used immediately after opening the package and destroyed afterwards.
b) The period of validity is five years from the date of manufacture, must use them in this period.
c) Do not use if inner packing is damaged; or the product is damp or moldy.
d) Store in a place where avoids high temperature, high humidity, and does not have corroding gases, should have good dryness and ventilation.
6 Production environment, package and sterilization
The production and assembly of all product parts and accessories are completed in relative clean workhouses which are in line with the requirements. Inner packing uses paper-plastic bag. And after large packing, all the products are sterilized by radiation for single use.
7 Classification of product
The products belong to the non-invasive, non-active, and are sterilized by radiation. According to MDD appendix IX classification rule 1, it is class I sterile medical device.
