FDA AAMI PB70:2012 Level-3 45gsm SMS Knitted Cuffs Dark Blue Surgical Gown
AAMI PB70:2012 Disposable Surgical Gown(Premarket Submission Number: K233183)
| Item Name | surgical gown (K233183) |
| Type | disposable medical devices |
| Material | SMS |
| Style | knitted cuffs, velcros back neck, waist ties |
| Size | XS-3XL |
| Weight | 45gsm |
| Color | dark blue |
| Standard | AAMI PB70:2012 Level-3 |
| Sterilization | steriled |
| Use For | surgical patient and operating room personnel |
| Item | SMS surgical (Premarket Submission Number:K233183) |
| Weight Per Square(g) | 45g/m2 |
|
Hydrostatic Pressure(cm)
AATCC-127
|
> 50cm |
| Water Impact | ≤1.0 g |
| Breaking Strength | >20N |
| Tearing Strength | >20N |
| Seam Strength | >30N |
| Flammability | Class I |
| EO Residue |
EO ≤ 4mg/d
ECH ≤ 9mg/d
|
| Shelf Life | 3 years |
| Barrier Protection Level | Level 3 per AAMI PB 70 |
- XS-3XL, various size for option
- steriled paper plastic bag, more hygiene away from contamination
- high quality multilayer SMS material: comfortable, drapable and have a tensile strength
- professional test(AAMI PB70:2012) and whole body design, provide reliable protection
| Packaging | 1pc/steriled paper plastic bag, 40bags/carton, can be adjusted by your requirements |
| Supply For | 50 Forty-Foot Container/Month |
| Payment | L/C, D/A, D/P, T/T, Western Union, , Paypal, etc |
| Ports | Wuhan, Shanghai, Guangzhou, etc |
| Sample | available |
| Lead Time | peak time: 1-3 months, off time: within 1 month |
Q1. How to make an inquiry?
A: Pls tell us the material, size, quantity of product you need, as well as your preferred delivery method. We welcome first time buyers. Simply send us pictures of the articles you need us to provide or tell us of your requirements. Welcome to email or call us, we will try our best to help.
Q2. Can we Design the packing with own LOGO?
A: Yes, we can produce all the packing based on your require, including the material of carton , color, design of mark and so on.
Q3. How about samples?
A: After confirming the price, we will supply free samples for you to check the quality, and make mass production after you confirm the sample
Q4. What certificates do you have?
A: We got the ISO13485, ISO9001, CE MDR certificate, UKCA, FDA 510K, Type5/6, EN14683.
Q5. What are your main products?
A: Our main products include disposable face mask, isolation gown, coverall, lab coat, surgical gown, disposable cap, apron, shoe cover, disposable gloves etc.
Q6.What are the payment terms?
A: We accept T/T(PayPal for small orders, Company account for regular orders), L/C at sight.
For established customers, we can discuss the L/C (extension of credit time) or DP payment, or other payment terms.
Q7.What if there is problem with the products after receiving?
A: We take pictures for you before shipping confirmation. If you note any production deficiencies, please send us notice (product pictures by email). We will correct what is not suitable or make other compensation.
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Have questions about our products or want to discuss a custom order? Our team is ready to help you.