FDA 510 (K) AAMI PB70: 2012 Level-3 SMS Disposable Surgical Gown with Knitted Cuffs
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Product Highlights
- SMS Material: Made of 45GSM SMS material, offering antibacterial, water-resistant, and skin-friendly comfort.
- Customizable Design: Features knitted cuffs, velcro collar, waist ties, and customized sizes for optimal fit.
- Certified Quality: Holds FDA, ISO13485, and CE MDR certifications, ensuring strict quality control standards.
- Versatile Application: Ideal for hospitals, operation rooms, and dental clinics, suitable for unisex use.
- OEM/ODM Service: Supports customization from samples, including logo printing and specific design adjustments.
Product Attributes
- Customization
- Available
- Material
- SMS
- Feature
- Disposable
- Model NO.
- 40083
- Certification
- FDA, ISO13485
- Ethylene Oxide Sterilization
- Ethylene Oxide Sterilization
- Application
- Hospital
- Group
- Unisex
- Logo Printing
- Without Logo Printing
- Color
- Dark Blue
- Level
- Pb70:2012 Level-3
- 510(K) No.
- K233183
- Weight
- 45GSM
- Style
- Knitted Cuffs, Velcros Collar, Waist Ties
- Applications
- Hospital, Operation Room, Dental Clinic, etc
- Transport Package
- 1PC/Bag, 40bags/Carton
- Specification
- XS-3XL
- Trademark
- OEM or ODM
- Origin
- Hubei, China
Product Images of FDA 510 (K) AAMI PB70: 2012 Level-3 SMS Disposable Surgical Gown with Knitted Cuffs
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FDA 510 (K) AAMI PB70: 2012 Level-3 SMS Disposable Surgical Gown with Knitted Cuffs -
FDA 510 (K) AAMI PB70: 2012 Level-3 SMS Disposable Surgical Gown with Knitted Cuffs -
FDA 510 (K) AAMI PB70: 2012 Level-3 SMS Disposable Surgical Gown with Knitted Cuffs -
FDA 510 (K) AAMI PB70: 2012 Level-3 SMS Disposable Surgical Gown with Knitted Cuffs -
FDA 510 (K) AAMI PB70: 2012 Level-3 SMS Disposable Surgical Gown with Knitted Cuffs
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Product Description
2. Made by SMS material, wearing-resistance, comfortable and non-irritating for skin
3. With knitted wrist and velcros back neck, convenient to wear on and adjuste lightness
4. Split desing for convenient to store, custmized size for better fit anyone
5. Ultrasonic heated selaed, no burr and high quality, provide good wearing experience
| 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 |
| Protection Level | Level 3 per AAMI PB 70 |
| 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, MoneyGram, Paypal, etc |
| Ports | Wuhan, Shanghai, Guangzhou, etc |
| Sample | available |
| Lead Time | peak time: 1-3 months, off time: within 1 month |
Q1: Are you a factory or trading company?
A: We are a both. No factory can see your all medical dreive inquires, only factory with trading company can help my clients to finish all of them needs.
Q2: Where is your factory located? How can I visit there?
A: Our factory is located in Xiantao (China's largest production base of non-woven products), only 35minutes train to Wuhan. You can fly to Tianhe Airport. Clients from home or abroad, are warmly welcome to visit us!
Q3: When can i get the price?
A: We usually quote within 24 our after got your inquiry. If you are urgent to get the price, please call us or tell us in your email so that we will regard your inquiry priority.
Q4: How can i get a sample to check your quality?
A: After price confirmation, you can require for samples to check our quality. If you just need a few samples to check the design and our quality, we will provide you samples for free, as long as you afford the express freight.
Q5: How long can I get to get the sample?
A: After you pay the sample charge and send us your confirmed information, the sample will be ready for delivery within 3-7 days. The sample will be sent to you via express and arrive in 3-5 workdays.
Q6: How does your factory do regarding quality control?
A: "Quality is priority. We always attach great importance to quality controlling from raw materials to the end. Our factory has gained CE MDR, ISO and FDA authentically.
About the Supplier
This supplier has been audited by SGS. Verify the report on the official SGS website with ID "QIP-ASR2491035". Items marked "
" are certified.
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Company Profile
Ammex-Weida (Hubei) Health and Safety Products Co., Ltd and Hubei Orient International Trading Corporation mainly specialize in healthcare products. We provide a wide range of disposable products for the safety and hygiene industries, as well as hospitals, food service and electronic industries, laboratories and cleanrooms, etc.
We've got CE, ISO9001, ISO13485, EN14683, UKCA, FDA 510K and Type 5/6 certificates.
With over eighteen years of region manufacturing experience, advanced equipment, from selecting the raw materials to the processing with the imported materials, to testing products, a series of strict management system and clean production environment, we can produce any quantities as your needs, duplicate your existing package design, and also create a package design that will uniquely brand your company' product. Ammex-Weida (Hubei) Health and Safety Products Co., Ltd specializes in the production of disposable nonwoven & plastic items, such as caps, face mask, lab coats, coveralls, isolation gown, oversleeves, apron, shoe covers, boot covers, etc.
All of us are just to offer you a strong shield of the best quality and price in the fiercely competitive market and to achieve a win-win situation. We believe our future will be more brilliant with your joining.
About Our Factory & Business Background
-
Business Type
- Manufacturer/Factory & Trading Company
- Address
- Room 505, Bldg No. 8, Soho Town, Cbd, Huaihai Road, Jianghan District, Wuhan, Hubei, China
-
Plant Area
- 19673.08 square meters
-
Number of Employees
- 50
-
Terms of Payment
- LC, T/T, D/P, PayPal, Western Union, Small-amount payment
-
International Commercial Terms(Incoterms)
- FOB, CIF, CFR, EXW
- Average Lead Time
-
Peak Season Lead Time: one month
Off Season Lead Time: within 15 workdays -
Nearest Port
- Wuhan Port
-
Minimum Order Quantity
- 100000 Pcs
-
Supply Chain Partners
- 38
Our Production Capability & Technical Expertise
-
Main Products
- Medical Face Mask, Isolation Gown, CPE Gown, Cap, Shoe/Boot Covers, Lab Coat, Scrub Suit, Oversleevs, Apron, Bed Sheet
-
Production Lines
- 5
-
Production Machines
- Face Mask Machine, Stripper Cap Machine, Shoe Cover Machine, Three & Four Thread Sewing Machine, Flat Sewing Machine, Vacuum Packaging Machine, Seal Machine, Electric Scissors, Pure Water System
-
QA/QC inspectors
- 2 people
-
Inspection Type for Finished Products
- 100% inspection(Visual inspection)
-
Inspection Method for Finished Products
- Have instructions and uniformly followed
-
Customization Options
- Customization from Samples
-
ODM Service Available
- Yes
-
OEM Service Available
- Yes
-
R&D Engineers
- 1 people
-
Traceability of Raw Materials
- Yes
-
Own Brand
- Yes
Our Industry Experience & Global Business Record
-
Year of Establishment
- 2003-07-08
-
Export Year
- 21 Years
-
Main Markets
- North America, South America, Europe, Southeast Asia/ Mideast, Africa, East Asia(Japan/ South Korea), Australia
-
Repeat Buyers Choice
- 80%~100%
-
Number of Foreign Trading Staff
- 8
-
Overseas Agent/Branch
- No
-
New Products Launched in Last year
- Yes
Our Certifications, Standards & Industry Recognition
-
Management System Certification
- ISO9001:2015, Others
FAQ
- Are you a factory or trading company?
- We are both. No factory can see your all medical dreive inquires, only factory with trading company can help my clients to finish all of them needs.
- Where is your factory located? How can I visit there?
- Our factory is located in Xiantao (China's largest production base of non-woven products), only 35minutes train to Wuhan. You can fly to Tianhe Airport. Clients from home or abroad, are warmly welcome to visit us!
- When can i get the price?
- We usually quote within 24 our after got your inquiry. If you are urgent to get the price, please call us or tell us in your email so that we will regard your inquiry priority.
- How can i get a sample to check your quality?
- After price confirmation, you can require for samples to check our quality. If you just need a few samples to check the design and our quality, we will provide you samples for free, as long as you afford the express freight.
- How long can I get to get the sample?
- After you pay the sample charge and send us your confirmed information, the sample will be ready for delivery within 3-7 days. The sample will be sent to you via express and arrive in 3-5 workdays.
- How does your factory do regarding quality control?
- 'Quality is priority. We always attach great importance to quality controlling from raw materials to the end. Our factory has gained CE MDR, ISO and FDA authentically.
- What is the MOQ for this product?
- The Minimum Order Quantity is 100,000 Pcs.
- What are the payment terms?
- We accept L/C, D/A, D/P, T/T, Western Union, MoneyGram, Paypal, and Small-amount payment.
Send your message to this supplier
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