Production Introduction
510K Surgical Gown Level 3
Our factory occupies 80,000 square meters, over 15,000 square meters of building area; own more than 150 large-advanced production equipments, more than 500 small process equipments. We has been distinguished with approvals and certifications such as FDA, CE, ISO13485:2003, along with that we also have plenty of experience on QSR820.
OEM and ODM are very welcomed! And have professional design team, can help you do design.
We work with integrity, and professionalism to satisfy our customers’ requirements. Our experienced innovate team will help our customers develop new projects with premier and the most updated Non-Woven trend in the world. Our products are currently being sold to over 54 countries around the globe.
Product Name | 510K Surgical Gown level 3 |
Materile | SMS 48gsm |
Test Report | AAMI Level 3 |
Sterile | EO Sterile |
Style | Ultrasonic Welding Seam |
Certificates | 510K / FDA / CE / ISO 13485 / ISO 13795 |
Advantage | 23years of production experience |
Main Products
510K Surgical Gown Level 3
Surgical Drapes Pack, Surgical Gown, Coverall / Overall, Face Mask, Isolation Gown
510K Approved Products
AAMI Level 3 Surgical Gown
AAMI Level 3 Isolation Gown
ASTM Level 3 Face Mask
ASTM Level 2 Face Mask
ASTM Level 1 Face Mask
What's ANSI/AAMI PB70
The ANSI/AAMI PB70 standard includes four standard tests for evaluating the barrier effectiveness of surgical gown, isolation gown, and surgical drape. Based on the results of these standardized tests, four levels of barrier performance are defined, with Level 1 being the lowest level of protection and Level 4 being the highest level of protection. Below table summarizes the ANSI/AAMI PB70:2012 requirements for the classification of barrier properties for surgical gowns, gowns, and drapes.
Below table: ANSI/AAMI PB 70:12 Barrier Performance Classification for Surgical Gowns, Other Protective Clothing, Drapes, and Drape Accessories.
| Level1 | Test | Liquid Challenge | Result | Expected Barrier Effectiveness |
| 1 | AATCC 42 Impact Penetration2 | Water | =4.5g | Minimal water resistance |
| 2 | AATCC 42 Impact Penetration | Water | =1.0g | Low water resistance |
| AATCC127 Hydrostatic Pressure3 | Water | =20cm | ||
| 3 | AATCC 42 Impact Penetration | Water | =1.0g | Moderate water resistance |
| AATCC127 Hydrostatic Pressure | Water | =50cm | ||
| 4 | ASTM F1671 Viral Penetration Test | Bacteriophage Phi-X174 | No penetration at 2psi(13.8kPa) | Blood and viral penetration resistance |
FAQ
Q: Can we use our own logo?
A: Yes, we can print your design on the package.
Q: Do you accept custom design on size?
A:Yes, if the size is reasonable
Q: How long is your delivery time?
A: The general delivery time is 20-30 days after order confirmation.
Q: Do you provide sample ? Any charge?
A: Yes, we supply free sample with freight collect.
Q: Do you have QC department?
A: Yes,we have 12 QC persons
Q: Which payment form you can accept?
A: T/T, LC
Q: Which certificate do you have?
A: 510K/FDA, CE, ISO13485.
Q: How to contact with you?
A: Email: lynn.w@medlinkindustry.com
Whatsapp: 86-186277161091
We are 510K Surgical Gown Level 3 suppliers, main produce Disposable Performance Surgical Gown in Blue, Green SMMS Surgical Gown for surgeon procedure, Sterile Universal Surgical Pack Assembly, Disposable Surgical Packs, AAMI leve 3 Disposable Protective Medical Gown, BVB 60g Surgical Gown AAMI Level 2 3 4.
As professional manufacturers, we do wholesale, welcome customized design. And we offer free sample with freight collect.
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