FDA Standard 510(K) AAMI PB70 Level-3 Blue Disposable Surgical Gown

Surgical gowns are an essential part of the personal protective equipment (PPE) worn by healthcare workers in the operating room, along with gloves, masks, and eye protection. They help to prevent the spread of infection and ensure the safety of both the surgical team and the patient.

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

Established in 2003, we cover 65,000 square meters with a team 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.

We utilize a complete quality management system ISO9001, ISO13485. We care about human rights and 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, UKCA.

Our medical face masks passed through Nelson's test and 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 comply with new European PPE Regulations (EU)2016/425 and are classified to type 3/4/5/6 and 3B/4B/5B/6B.

• Face mask: disposable nonwoven face mask, surgical facemask, active carbon face mask, dust mask, N95 mask, paper mask, etc.
• Surgical gown: surgical gown, PP/PE gown, isolation gown, SMS surgical gown, sterile surgical gown, patient gown, etc.
• Coverall: disposable PP coverall, PP/PE coverall, SMS coverall, Microporous coverall (with/without hood, with/without boots, any color)
• Lab coat: disposable lab coat, PP lab coat, SMS lab coat, Microporous lab coat, visitor coat, PP/PE/Tyvek apron
• Caps: doctor caps, bouffant caps, round caps, clip caps, non woven caps
• Sleeve/shoe cover: PP sleeve cover, PE sleeve cover, SMS sleeve cover, Microporous sleeve cover, non skid shoe cover, PE/CPE shoe cover
• Beauty Products: Nonwoven kimono, mantle, hair band, slipper, PE shower cap and so on