FDA 510K Level-3 Steriled Package Disposable Medical Surgical Gown With Knitted Cuffs

Product Description

PB70:2012 Level-3 Surgical Gown

1. made by SMS fabric: soft, drapable, breathable, wear-resistance and easy to work with
2. XS-3XL, various size for all people
3. steriled package, more hygiene and effective
4. meet AAMI PB70:2012 Level-3 requirements, provide professional and strong protection
5. velcros collat design for adjust flexibly and wearing comfortably

Hubei TDL Group is made of Hubei Orient International Trading Corporation and Ammex-weida(Hubei) Health and Safety products Co.,Ltd. We specilize in the design,manufacturing and sales of disposable medical products and PPE products for more than 20 years.

Ammex-weida established in 2003,covering 65,000 square meters. We are a group of more than 500 individuals. Ammex-weida is equipped with a medical and industrial laboratory in class 10000, clean room workshops in class 100000 for sterile medical devices and all kinds of disposable products. Our disposable products are exported to more than 60 countries and regions in Europe, America, Asia, Middle East etc.

Ammex-weida utilizes a complete quality management system ISO9001, ISO13485. We care about human rights and we are certified by human right agency of SEDEX. Ammex-weida has medical device license for class I and II. Our products are certified with CE,FDA. Our medical face masks passed through Nelson's test. Our medical face masks are conform to EN14683 type II and type IIR for Europe market, ASTM level 3 510K for North America and the national standard YY0469 and YY0969 for China market. Our category III protective coveralls are complied with new European PPE Regulations (EU)2016/425. They are classified to type 3/4/5/6 and 3B/4B/5B/6B. And we' ve passed AAMI PB70:2012 Level-3 test for disposable surgical gown.

Our group has more than 20 individuals for QC quality control, laboratory and inspection.Our laboratory could do tests for face masks such as particulate filtration efficiency, differential pressure, Synthetic blood penetration,Tensile test for earloop,flammability test,microbial cleanliness,splash resistance,sterile test, ethylene oxide residue etc.And also we could do tests for coveralls such as hydro-static pressure, Repellency by liquids, Resistance to Penetration by liquids,Surface Resistance, Resistance to Ignition,filtering efficiency,Puncture Resistance,Tensile strength,static decay period,sterile test, ethylene oxide residue etc.

Ammex-weida is situated in Xiantao,Hubei province,the famous nonwoven products base in China.Almost 50% disposable nonwoven medical products and nonwoven healthcare products are produced in Xiantao.The traffic is very convenient. Xiantao is 100km from Wuhan Yangluo port,100km from Wuhan Tianhe airport, 10km from Xiantao railway station.

Ammex-weida welcomes you!

Q1: Are you a factory or trading company?
A: We are a both. No factory can see your all medical dreive inquires, only factory with trading company can help my clients to finish all of them needs.

Q2: Where is your factory located? How can I visit there?
A: Our factory is located in Xiantao (China's largest production base of non-woven products), only 35minutes train to Wuhan. You can fly to Tianhe Airport. Clients from home or abroad, are warmly welcome to visit us!

Q3: When can i get the price?
A: We usually quote within 24 our after got your inquiry. If you are urgent to get the price, please call us or tell us in your email so that we will regard your inquiry priority.

Q4: How can i get a sample to check your quality?
A: After price confirmation, you can require for samples to check our quality. If you just need a few samples to check the design and our quality, we will provide you samples for free, as long as you afford the express freight.

Q5: How long can I get to get the sample?
A: After you pay the sample charge and send us your confirmed information, the sample will be ready for delivery within 3-7 days. The sample will be sent to you via express and arrive in 3-5 workdays.

Q6: How does your factory do regarding quality control?
A: "Quality is priority. We always attach great importance to quality controlling from raw materials to the end. Our factory has gained CE MDR, ISO and FDA authentically.