Medical Supply Gown Waterproof PP&PE Isolation Gown Hospital Sterile Nonreinforced Eclipse Surgical Gowns with Towel
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Product Highlights
- AAMI Level 2 & 3 Protection: Tested and classified as AAMI Level 2 in critical zones and Level 3 at reinforced areas per PB70:2012 standard.
- Customizable Materials & Colors: Available in PP+PE, SMS, or nonwoven fabrics with Blue, White, Red, Yellow, and other color options.
- FDA Regulated Class II Device: Complies with FDA 510(k) premarket notification requirements for surgical and isolation gowns.
- Advanced Sterilization Standards: Sterilized following ISO 11135-1:2007 and ISO 13485 standards for medical safety.
- Hypoallergenic Latex-Free: Made without natural rubber latex to provide a safe PPE solution for sensitive users.
- Ergonomic Raglan Sleeve Design: Features RaglanPlus sleeves for freedom of movement and integrated thumb loops for full protection.
- GMP Compliant Manufacturing: Produced in 100,000 to 300,000 level dust-free workshops meeting GMP requirements.
- ISO 13485 & CE Certified: Holds ISO 13485 and CE certifications ensuring international quality and safety compliance.
Product Attributes
- Customization
- Available
- Feature
- Anti-Bacterial, Breathable, Waterproof
- Pattern
- Plain
- Usage
- Garment, Medical
- Materials
- PP+PE. Others
- Color
- Blue, White, Red, Yellow etc
- Material
- 100% Polypropylene
- Style
- Flocked
- Technics
- Melt-Blown
- Weight Range
- 10-200GSM
- Application
- Disposable Supplies
- Grade
- Domestic
- Width
- 120-140cm
- Transport Package
- 100PCS/Carton
- Specification
- all sizes
- Trademark
- BINFEI
- Origin
- China
- HS Code
- 6210103090
- Production Capacity
- 250000PCS/Day
Product Images of Medical Supply Gown Waterproof PP&PE Isolation Gown Hospital Sterile Nonreinforced Eclipse Surgical Gowns with Towel
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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 |
| wrist style | elastic wrist, thumb loop |
| Neck style | neck tie, over head style |
| color | blue&white etc. |
| size | 120-140cm etc. |
| inner pack | 100pcs/carton |
| OEM | available |
| certificate | ISO13485&CE |
| Advantage | Cheap/waterproof |
- Open-back design allows for increased airflow and comfort
- Easy-to-don/doff design features closed-loop neck allowing user to slip the gown over the head and tear off quickly and conveniently
- Long sleeves feature integrated thumb loops to maintain full protection from fluids and infectious material through the wrist and makes donning gloves easy
- Waist ties secure gown on user to maintain level 2 protection in critical zones
- Tested and classified as AAMI Level 2 in the critical zones per AAMI Standard PB70:2012
- Universal, light blue design to fit most users and implied procedural use for convenience
- Made from soft, fluid-resistant polyethylene to help ensure protection and comfort
- Designed to help protect healthcare professionals during medical procedures
- Not made with natural rubber latex to provide a hypoallergenic PPE solution
- Not intended to be used in a surgical setting or in the presence of high intensity heat source or flammable gas
- 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
- Lightweight, fluid-repelling polypropylene material provides basic protection for the myriad of challenges faced by staff.
- Generously sized for full coverage and flexibility.
- Available with classic neck / waist ties and elastic wrists or over-the-head style neck with thumb loop wrists.

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 partner, 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 bidding or 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, L/C 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.
Through the family-owned factory alliance, we have a strong production capacity and cargo delivery capabilities. Our excellent social reputation and contract performance records are the basement of equal and friendly cooperation with international friends. Whether you are in any market, our company is willing to wholeheartedly help you seize the market commanding heights and occupy more market share. Looking forward to your visit and cooperation.
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 protection levels does this gown offer?
- The gown is tested and classified as AAMI Level 2 in critical zones and AAMI Level 3 at reinforced areas per AAMI Standard PB70:2012.
- Can the material and color be customized?
- Yes, materials include PP+PE, SMS, or nonwoven fabric, and colors are available in Blue, White, Red, Yellow, etc.
- Is this product FDA regulated?
- Yes, surgical gowns are regulated by the FDA as a Class II medical device requiring 510(k) premarket notification.
- What sterilization standards are followed?
- Sterile styles follow ISO 11135-1:2007 and ISO 13485 standards to ensure safety and efficacy.
- Are the gowns made with latex?
- No, they are not made with natural rubber latex, providing a hypoallergenic PPE solution.
- What are the available sizes?
- Sizes include M, L, XL, and XXL to fit most users comfortably.
- What is the lead time for orders?
- Peak season lead time is one month, while off-season lead time is within 15 workdays.
- Does the company have its own factory?
- Yes, we own a factory established in 2015 with 100,000 square meters in Shandong and 100 square meters in Hefei office.
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