Import Ce/Fda Certified Aami Level 1-4 Surgical Gowns — Buy in wholesale FOB from Supplier in France
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Fruits Shop supplies CE and FDA certified surgical gowns compliant with AAMI PB70:2012 standards, rated for protection levels 1 through 4. Each gown is constructed from non-woven polypropylene fabric with a polyethylene backsheet, offering fluid resistance certified to ASTM F1670 and ASTM F1671. The gowns feature elasticated wrists, tie-back closures, and extended coverage for high-risk procedures, with no latex or powder used in manufacturing.
The material composition is typical of Level 1-4 surgical gowns in the medical textile industry, with barrier performance calibrated to resist synthetic blood penetration at varying pressures. Level 1 gowns suit low-risk settings like routine exams, while Level 4 gowns meet the highest fluid barrier requirements for long, invasive surgeries. Fabric weight ranges from 35 to 55 gsm, with seam sealing applied using ultrasonic welding to prevent leakage at stress points.
These gowns are sourced by hospitals in the Hauts-de-France region, private clinics, and emergency response units requiring bulk sterilized supply. Orders are fulfilled in cartons of 50 or 100 units, packed in sterile peel-pouches. Trade terms include FOB and CIF, with packaging labeled per EU MDR and FDA guidelines. Buyers should confirm batch traceability and sterilization method prior to acceptance.
| Material | Non-woven polypropylene with polyethylene backsheet |
| Certification | CE Marked, FDA Registered, AAMI PB70:2012 Level 1-4 |
| Fluid Resistance | ASTM F1670 (synthetic blood) and ASTM F1671 (viral penetration) tested |
| Fabric Weight | 35 to 55 gsm, typical for medical non-woven surgical gowns |
| Seam Construction | Ultrasonically sealed seams, standard for high-barrier surgical apparel |
| Closure Type | Tie-back neck and waist, with elasticated wrist openings |
| Sterilization Method | Ethylene oxide (EtO) sterilized, typical for single-use medical garments |
| Packaging | Sterile peel-pouches, 50 or 100 units per carton |
| Latex Content | Latex-free, compliant with EU REACH and FDA guidelines |
| Color | Typical surgical blue or green, standard for clinical environments |
Fruits Shop operates from Henin-Beaumont in the Hauts-de-France region, with a registered business address and physical presence in France. The supplier is classified as a harbor-tier entity on the platform, indicating verified legal registration and compliance with EU trade documentation requirements. There is no public information on production capacity, workforce size, or years in operation.
The company specializes in sourcing and distributing certified medical protective apparel, with no indication of manufacturing capability. Its listing reflects a distributor or importer role rather than a factory. Response metrics show no recorded communication history, suggesting buyers should initiate direct inquiry for order confirmation and documentation.
| 企业类型 | Supplier |
| 成立年份 | Contact Supplier |
| Employees | Contact Supplier |
| Annual Revenue | Contact Supplier |
| Main Products | View Products Tab |
| Major Markets | Global |
| 响应时间 | <4h |
| 响应率 | Contact Supplier |
Sourcing CE/FDA Certified AAMI Level 1-4 Surgical Gowns from Fruits Shop - France Import Guide
Before placing an order, verify the batch-specific CE Declaration of Conformity and FDA Establishment Registration number. Confirm that the gowns are labeled with lot number, expiry, sterilization method, and AAMI level on each pouch. Request a sample for barrier and fit evaluation, especially if used in high-risk surgical settings. Ensure the supplier provides traceability from raw material to final product.
Confirm the Incoterms and delivery method, as FOB or CIF will determine responsibility for customs clearance and insurance. Lead times for sterilized batches typically range from 21 to 30 days from order confirmation. Payment terms are usually T/T in advance or LC at sight. Buyers should request a packing list matching the EU MDR labeling requirements.
Perform incoming inspection for seal integrity, packaging damage, and correct labeling. Use a moisture indicator card to verify dry storage conditions. Check that each carton includes a sterility certificate and batch test report. Reject any gowns with visible tears, discoloration, or missing labels. Retain samples for 2 years post-use for audit compliance under EU MDR.
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30 suppliersBuy Ce/Fda Certified Aami Lev in Bulk — Verified Supplier in France
When sourcing Ce/Fda Certified Aami Level 1-4 Surgical Gowns for your business, securing the right balance of quality and cost is essential. Fruits Shop, a verified supplier based in France, offers this product for international export. By purchasing directly from the manufacturer or authorized exporter, buyers can negotiate favorable FOB prices starting at $1.2/Bags and manage bulk orders with a minimum order quantity (MOQ) of 1 Bags. This product is a staple in the Tea sector with strong demand from importing countries worldwide.
Ce/Fda Certified Aami Lev Specifications, Trade Terms & Pricing
Importing Ce/Fda Certified Aami Lev requires careful attention to shipping logistics, customs compliance, and secure payment terms. Fruits Shop offers flexible shipping options such as Full Container Load (FCL) or Less than Container Load (LCL) via sea freight. Common payment methods for international B2B transactions include Letter of Credit (L/C), Telegraphic Transfer (T/T), and Documents against Payment (D/P). All transactions and RFQs are facilitated through EximNext, a leading online B2B marketplace designed to make cross-border trade secure and efficient.
About Fruits Shop — Supplier in France
Finding trustworthy partners is the foundation of successful importing. The supplier of this Ce/Fda Certified Aami Lev has been verified on our platform. Whether you are a distributor, wholesaler, or procurement manager, you can request a free quotation, ask for product samples, and finalize your bulk purchase with confidence. EximNext hosts thousands of verified manufacturers and exporters across 200+ countries. Explore similar products in the Tea category and connect with top-tier exporters on our comprehensive B2B marketplace. Start your sourcing journey today.
Import Ce/Fda Certified Aami Lev — Shipping, Logistics & Customs
Importing Ce/Fda Certified Aami Lev requires careful attention to shipping logistics, customs compliance, and secure payment terms. Common shipping options include Full Container Load (FCL) or Less than Container Load (LCL) via sea freight. Buyers should verify import duties in their destination country. Common payment methods include Letter of Credit (L/C), Telegraphic Transfer (T/T), and Documents against Payment (D/P).
Frequently Asked Questions About Ce/Fda Certified Aami Lev
What is the wholesale price of Ce/Fda Certified Aami Level 1-4 Surgical Gowns?
The current listed wholesale price for Ce/Fda Certified Aami Level 1-4 Surgical Gowns from Fruits Shop is $1.2/Bags on FOB terms from France. Prices may vary depending on order volume, packaging, and destination. For the most accurate bulk quote, send a direct RFQ to Fruits Shop through EximNext.
What is the Minimum Order Quantity (MOQ) for Ce/Fda Certified Aami Lev?
The supplier, Fruits Shop, has set a Minimum Order Quantity (MOQ) of 1 Bags for Ce/Fda Certified Aami Lev. For sample requests or smaller trial orders, contact the supplier directly through our platform's inquiry system.
What is the HS Code for Ce/Fda Certified Aami Level 1-4 Surgical Gowns?
The HS Code classification for Ce/Fda Certified Aami Level 1-4 Surgical Gowns depends on the specific grade and form. Contact Fruits Shop through EximNext for the exact HS Code and customs documentation required for your destination country.
How can I import Ce/Fda Certified Aami Lev from France?
To import Ce/Fda Certified Aami Lev from France, negotiate shipping terms (FOB, CIF, or EXW) directly with Fruits Shop. Ensure you have the necessary import licenses for Tea products in your destination country.
Is Fruits Shop a verified supplier?
Yes, Fruits Shop is a verified supplier on EximNext. You can view their complete company profile, business registration details, certifications, and export history before placing a bulk order.
What are the key specifications of Ce/Fda Certified Aami Level 1-4 Surgical Gowns?
For a complete technical data sheet or Certificate of Analysis (COA), send an inquiry directly to Fruits Shop through EximNext.
What packaging options are available for bulk orders of Ce/Fda Certified Aami Lev?
Fruits Shop offers Ce/Fda Certified Aami Lev with standard export packaging. Custom packaging, private labeling, and OEM/ODM options may also be available for large wholesale orders.
Which countries import Ce/Fda Certified Aami Lev the most?
Ce/Fda Certified Aami Lev is actively imported by buyers worldwide. Request a destination-specific CIF or CFR quote from Fruits Shop through our platform.
What certifications does this Ce/Fda Certified Aami Lev supplier hold?
Fruits Shop maintains international quality certifications. These ensure that the Ce/Fda Certified Aami Lev meets international quality, safety, and regulatory standards required for cross-border trade.
How do I place a bulk order for Ce/Fda Certified Aami Level 1-4 Surgical Gowns on EximNext?
Click "Request Quotation" on this product page, specify your required quantity, preferred shipping terms, and destination country. Fruits Shop will respond with a detailed wholesale quote including FOB pricing, lead time, and payment options.
What payment methods are accepted?
Common payment methods include Letter of Credit (L/C), Telegraphic Transfer (T/T), Documents against Payment (D/P), and Escrow services. Confirm accepted terms directly with Fruits Shop.
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