Medical Gowns Waterproof Sterile Disposable Isolation Gown Surgical Gown with Rib Cuff
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Product Highlights
- AAMI Level 3 Protection: Reinforced area meets AAMI Level 3 standard for high-risk surgical procedures.
- Customizable Materials: Available in PP+PE, PP, or SMS fabric to suit specific needs.
- Multiple Color Options: Offered in Blue, White, Red, Yellow, and Green to match facility requirements.
- Raglan Sleeve Design: Provides freedom of movement with ultra-sonically sealed or thermal-bonded sleeves.
- ISO 13485 Certified: Manufactured in GMP-compliant facilities with strict quality control systems.
- Ethylene Oxide Sterilization: Sterilized following ISO 11135-1: 2007 standard for guaranteed safety.
- Secure Neck Closure: Features convenient hook and loop closures for a custom, secure fit.
- FDA Class II Compliant: Regulated as a Class II medical device requiring 510(k) premarket notification.
Product Attributes
- Customization
- Available
- Type
- Surgical Supplies Materials
- Material
- Non-woven Fabric
- Ethylene Oxide Sterilization
- Ethylene Oxide Sterilization
- Quality Guarantee Period
- Two Years
- Group
- Adult
- Logo Printing
- Without Logo Printing
- Materials
- PP+PE
- Color
- Blue, White, Red, Yellow etc
- Transport Package
- 100PCS/Carton
- Specification
- all sizes
- Trademark
- BINFEI
- Origin
- China
- HS Code
- 6210103090
- Production Capacity
- 250000PCS/Day
Product Images of Medical Gowns Waterproof Sterile Disposable Isolation Gown Surgical Gown with Rib Cuff
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Product Description
- Varying levels of protection.
- Ultra-sonically sealed, thermal-bonded or glued sleeve design.
- Freedom of movement with our customer RaglanPlus sleeve design.
- Low-linting, breathable material construction.
- Custom, secure-fit with convenient hook and loop neck closures.
- Preferred knit cuff design.
- Meet the Standard for Flammability of Clothing Textiles CPSC 16 CFR Part 1610.
- Limited to Sterile Items only at this time.
Disposable Surgical Gowns
Disposable surgical gowns are clothes worn by surgeons and other medical staff during operations in the operating room. In addition, a disposable sterile gown protects the patient and healthcare workers from infection during the operation. Moreover, the disposable surgical gowns comply with international surgical gown standards such as EN13795 and AAMI PB70.
As a professional surgical gown manufacturer, we insist on selecting suitable materials, adopting advanced production techniques, and strict quality control systems to provide your medical staff with various types of sterile gowns online. In addition, we have set up production plants and workshops according to GMP requirements, and the purification and asepsis have reached 100000 or 300000 levels of the dust-free environment.
| material | nonwoven fabric&PP+PE&PP&SMS |
| color | blue&white etc. |
| size | 39cm&40cm etc. |
| inner pack | 100pcs/carton |
| OEM | available |
| certificate | ISO13485&CE |
| Advantage | Cheap/waterproof |
- SMS reinforced gown, the chest and sleeve area are reinforced with an additional layer of SMS material
- Meet ASTM F2407 standard
- Sterile style: Sterilization followed by ISO 11135-1: 2007 standard
- Raglan sleeves, hook and loop neck closures, and tie waist closures
- AAMI Level 3 at the reinforced area
- At the non-reinforced area
- Material: 100 % SMS
- Fabric weight: 45gsm
- Color: Blue
- Size: M, L, XL, XXL
- Packing: 25pcs/ carton
- Knitted cuff type
- PP+PE
- Meet ASTM F2407 standard
- Sterile style: Sterilization followed by ISO 13485 standard
- Raglan sleeves, hook and loop neck closures, and tie waist closures
- AAMI Level 3 at the reinforced area
- At the non-reinforced area
- Fabric weight: 45gsm
- Color: Blue
- Size: M, L, XL, XXL
- Packing: 100pcs/ carton
- Knitted cuff type
- PP gown
- Meet ASTM F2407 standard
- Sterile style: Sterilization followed by ISO 13485 standard
- Raglan sleeves, hook and loop neck closures, and tie waist closures
- AAMI Level 2 at the reinforced area
- At the non-reinforced area
- Material: 100 % PP
- Fabric weight: 15gsm
- Color: Blue/Green/yellow
- Size: M, L, XL, XXL
- Packing: 100pcs/ carton
- Knitted cuff type

Regards to Surgical Gown
According to FDA, A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. A surgical gown is a personal protective garment intended to be worn by health care personnel during surgical procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate matter.
Because of the controlled nature of surgical procedures, critical zones of protection have been described by national standards. As referenced in Figure 1: the critical zones include the front of the body from the top of shoulders to knees and the arms from the wrist cuff to above the elbow. Surgical gowns can be used for any risk level (Levels 1-4). All surgical gowns must be labeled as surgical gowns.
Source FDA
Regards to Surgical Isolation Gown
Surgical isolation gowns are used when there is a medium to high risk of contamination and a need for larger critical zones than traditional surgical gowns. Surgical isolation gowns are regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification.
All areas of the surgical isolation gown except bindings, cuffs, and hems are considered critical zones of protection and must meet the highest liquid barrier protection level for which the gown is rated. All seams must have the same liquid barrier protection as the rest of the gown. Additionally, the fabric of the surgical isolation gown should cover as much of the body as is appropriate for the intended use.
Source FDA
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About the Supplier
Company Profile
Zhucheng Binfei Medi-Tek Co., Ltd., As a reliable manfuacturer, we provide OEM service with very good quotation, price is very competitive, meanwhile high quality is our life, no matter what happened we're always responsable for our goods forever, our products had been exported to EU, the UK, Middle East, USA, South America, Southeast Asia, you can rest assured that all cargo will be shipped to you fluently. CE, ISO and other certificates test reports can be offered, we'll do our best to support you for registering. We're specilized on medical disposable products, especially Personal Pretective Equipment, sterilization products and dental consumables. Once you cooperate with us, we will offer 24hrs service for your orders, also update processes in time, our workers are very professional and works very fast, they help us give you faster leading time, your goods will be shipped out on time. No matter where you are from, our logistics department can offer you the most cheapest shipping cost for your reference, try our best to reduce your purchase cost, at the same time, EXW, DAP, FOB, CIF, DDP is available for trade terms, assist you deal with all kinds of barriers of importing&purchasing. In a word, we provide you High Quality, better price, faster production, cheap freight, safety transaction, more supports for your business, sincerely looking forward to cooperating with your team.
We aim to provide best OEM service, best price and the shortest leading time for our customers!
We adhere to the management principles of "quality first, customer first and credit-based" since the establishment of the company and always do our best to satisfy potential needs of our customers. Our company is sincerely willing to cooperate with enterprises from all over the world in order to realize a win-win situation since the trend of economic globalization has developed with anirresistible force.
About Our Factory & Business Background
- Address
- Sunjia Bashan Village, Changcheng Town, Weifang, Shandong, China
- Terms of Payment
- LC, T/T, D/P, Western Union
- International Commercial Terms(Incoterms)
- FOB, EXW, CFR, CIF, FAS, DDP, DAP, FCA
- Average Lead Time
-
Peak Season Lead Time: one month
Off Season Lead Time: within 15 workdays - Nearest Port
- Qingdao, Shanghai
Our Production Capability & Technical Expertise
Our Industry Experience & Global Business Record
- Export Year
- 2018-05-01
- Main Markets
- North America, South America, Eastern Europe, Southeast Asia, Africa, Oceania, Mid East, Eastern Asia, Western Europe
FAQ
- What materials are available for the gown?
- We offer materials including Non-woven Fabric, PP+PE, PP, and SMS.
- What colors can be customized?
- Custom colors include Blue, White, Red, Yellow, and Green.
- What is the lead time for orders?
- Peak season lead time is one month, while off-season is within 15 workdays.
- Does the product meet international standards?
- Yes, it meets EN13795, AAMI PB70, ASTM F2407, and ISO 13485 standards.
- What is the packaging quantity per carton?
- Packaging options include 25pcs/carton or 100pcs/carton depending on the type.
- Are the gowns sterile?
- Yes, they are sterilized using Ethylene Oxide following ISO 11135-1: 2007.
- What is the warranty period?
- The quality guarantee period is two years.
- What are the available sizes?
- Sizes include M, L, XL, and XXL.
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