Disposable Surgical Gown (AAMI PB70 Level-3)
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.
| Style | non-reinforced, knitted cuffs, velcro neck |
| Barrier Protection Level | Level-3 per AAMI PB70 |
| Color | blue |
| Sterilization Method | EO sterilization |
| Size | XS-3XL |
| Packaging | 1pc/paper+pe sterilized bag, 40bags/ctn |
| Applications | operation, dental clinic or other medical instituions |
| Shelf Life | three years |
Product Test Data:
510K number | K233183 |
Hydrostatic Pressure(cm) AATCC-127 | >50 cm |
Water impact AATCC-42 | ≤1.0 g |
Seam Strength | >30N |
EO residue | EO ≤ 4mg/d ECH ≤ 9mg/d |
About Us:
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.
We 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 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.
We 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, UKCA. 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.
Our Product Lines:
1. Face mask: disposable nonwoven face mask, surgical facemask, active carbon face mask, dust mask, N95 mask, paper mask, etc.
2. Surgical gown: surgical gown, PP/PE gown, isolation gown, SMS surgical gown, sterile surgical gown, patient gown, etc.
3. Coverall:disposable PP coverall, PP/PE coverall, SMS coverall , Microporous coverall (with/without hood, with/without boots, any color.)
4. Lab coat: disposable lab coat, PP lab coat, SMS lab coat, Microporous lab coat, vistor coat, PP/PE/Tyvek apron.
5. Caps: doctor caps, bouffant caps, round caps, clip caps, non woven caps
6. Sleeve/shoe cover: PP sleeve cover, pe sleeve cover, SMS sleeve cover, Microporous sleeve cover, non skid shoe cover, PE/CPE shoe cover
7. Beauty Products- Nonwoven kimono, mantle, hair band, slipper, PE shower cap and so on.
Product Tags:
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FDA Standard 510(K) AAMI PB70 Level-3 Blue Disposable Surgical Gown Images
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