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

Minimum Order Quantity : 30 cartons Price : Negotiation
Packaging Details : 1pc/paper+pe sterilized bag, 40bags/ctn Delivery Time : peak time: above 1 month, off time: within 1 month
Payment Terms : L/C,D/A,D/P,T/T,Western Union, Supply Ability : Around 50 x 40'HQ/Month
Place of Origin: Xiantao, Hubei Brand Name: JINLIANG or OEM
Certification: AAMI PB70 Level-3 Model Number: 40083-L3

Detail Information

Style: Non-reinforced, Knitted Cuffs, Velcro Neck Size: XS-3XL
Sterilization Method: EO Sterilization Color: Blue
Barrier Protection Level: Level 3 Per AAMI PB 70 Hydrostatic Pressure(cm) AATCC-127: >50cm
Use: Single Use Shelf Life: Three Years
Highlight:

FDA standard disposable surgical gown

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AAMI PB70 Level 3 surgical gown

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blue disposable surgical gown

Product Description

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

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.

Blue disposable surgical gown product image
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 institutions
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 Our Company

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.

Our group has more than 20 quality control professionals for laboratory and inspection. Our laboratory conducts comprehensive testing including:

  • Face masks: particulate filtration efficiency, differential pressure, synthetic blood penetration, tensile test for earloops, flammability test, microbial cleanliness, splash resistance, sterile test, ethylene oxide residue
  • Coveralls: 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
Company facilities and manufacturing environment

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.

Quality certifications and manufacturing processes
Our Product Lines
  • 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

Get in touch with us

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selenazjq@hborient.com
+13986047343
86-13237136291
zjq812@hotmail.com
86-27-85577096/85577097