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The product is a sterile, single‑use surgical gown that complies with FDA 510(k) clearance and the AAMI PB70 Level 4 fluid barrier classification. It is constructed from Triplex SMS nonwoven polypropylene fabric and is supplied in sizes ranging from S to XXXL. Each gown is ethylene‑oxide sterilised and packed individually in a sterile pouch, ready for immediate use in the operating theatre. The supplier markets the gown for mid‑to‑long duration procedures and offers bulk pricing for hospital procurement and international medical importers.
Triplex SMS combines three layers of spunbond and meltblown fabric, delivering a high‑density barrier that meets the stringent requirements of Level 4 protection. In the industry, Level 4 gowns typically have a weight between 80 g m⁻² and 120 g m⁻² and exhibit a minimum tensile strength of about 25 N/tex. The material also provides sufficient breathability to maintain wearer comfort during extended surgeries, while preventing fluid penetration. These characteristics align with the AAMI PB70 standard and are widely recognised across global healthcare markets.
Primary users are hospitals, surgical centres and government health agencies that need the highest barrier performance for invasive procedures. Procurement officers usually request certification copies and may specify size mixes to match staff uniform programmes. Because the listing does not disclose minimum order quantities, payment terms or exact lead times, interested buyers should confirm those details directly with Medcare Healthcare Co. before placing an order.
| Material | Triplex SMS Nonwoven Polypropylene Fabric |
| AAMI Classification | Level 4 fluid barrier (per AAMI PB70) |
| FDA Status | FDA 510(k) cleared |
| Available Sizes | S, M, L, XL, XXL, XXXL |
| Sterilisation Method | Ethylene oxide (EO) sterilised |
| Packaging | Individually packaged sterile pouch |
| Typical GSM | typical 80‑120 gsm for Level 4 gowns |
| Typical Tensile Strength | typical ≥25 N/tex for SMS fabric |
| Typical Breathability | typical 5 mm H₂O water vapor transmission rate |
Medcare Healthcare Co. is based at Fatih Mh. Camlik St. No:54, 35414 Sarn, Izmir, Turkey. The supplier is listed with a harbor trust tier and currently shows a response rate of 0 % with no average response time recorded, indicating that contact may require follow‑up through formal request channels. The company’s catalogue highlights sterile surgical apparel, focusing on high‑performance gowns that meet international regulatory standards.
The listing specifies that Medcare supplies single‑use, EO‑sterilised gowns meeting FDA 510(k) and AAMI PB70 Level 4 criteria, but it does not provide additional corporate history, production capacity or client references. Buyers should therefore request detailed company documentation, such as a corporate profile or factory audit reports, to assess the supplier’s operational capabilities before committing to large‑scale procurement.
Level 4 sterile surgical gown compliant with FDA 510(k) and AAMI PB70 standard, designed to protect patients and OR personnel from microorganism transfer. Made from triplex SMS nonwoven fabric with Level 4 fluid barrier performance, available in sizes S through XXXL. Single-use, EO sterilized, individually packaged. Ideal for mid-to-long duration surgical procedures. Bulk pricing available for hospital procurement and international medical supply importers.
| Business Type | Supplier |
| Year Established | Recently Joined |
| Employees | Contact Supplier |
| Annual Revenue | Contact Supplier |
| Main Products | View Products Tab |
| Major Markets | Global |
| Response Time | Contact Supplier |
| Response Rate | New Supplier |
Before placing an order, verify that the gowns hold a valid FDA 510(k) clearance and an AAMI PB70 Level 4 certification. Request copies of the certification documents, as well as the EO sterilisation validation report, to confirm compliance with the stated specifications. It is also advisable to check the supplier’s quality management system, such as ISO 13485 registration, if applicable.
Confirm logistics details early: ask the supplier which Incoterms they support, typical lead time from order confirmation to shipment, and the preferred payment method. Because the listing does not disclose these terms, a written quotation should include freight options, port of loading in Turkey, and any applicable customs duties. Align these details with your import schedule to avoid delays.
Arrange a third‑party inspection of the finished gowns prior to loading, focusing on material integrity, seam strength and sterility assurance. Request a Certificate of Sterility and a test report for fluid barrier performance based on ASTM 1670/1671 or equivalent. Maintaining these quality checks will help ensure that the gowns meet the required safety standards for your medical facilities.
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When sourcing Surgical Gown Level 4, Fda510k for your business, securing the right balance of quality and cost is essential. Medcare Healthcare Co., a verified supplier based in Turkey, offers this product with key specifications including AAMI PB70 Level 4 / ANSI/AAMI PB70, Triplex SMS (Spunbond-Meltblown-Spunbond) Polypropylene Nonwoven, and S, M, L, XL, XXL, XXXL. By purchasing directly from the manufacturer or authorized exporter, buyers can negotiate favorable FOB prices starting at $25/Bags and manage bulk orders with a minimum order quantity (MOQ) of 1 Bags. This product is actively traded under HS Code 6210.10, making it a staple in the Disposable Gowns sector with strong demand from importing countries worldwide.
Importing Surgical Gown Level 4, Fd requires careful attention to shipping logistics, customs compliance, and secure payment terms. Medcare Healthcare Co. offers flexible shipping options such as Full Container Load (FCL) or Less than Container Load (LCL) via sea freight. To ensure a smooth transaction, buyers should verify import duties for HS Code 6210.10 in their destination country. 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 global B2B marketplace designed to make cross-border trade secure and efficient.
Finding trustworthy partners is the foundation of successful importing. The supplier of this Surgical Gown Level 4, Fd 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 Disposable Gowns category and connect with top-tier exporters on our comprehensive import export marketplace. Start your sourcing journey today.
Importing Surgical Gown Level 4, Fd 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 for HS Code 6210.10 in their destination country. Common payment methods include Letter of Credit (L/C), Telegraphic Transfer (T/T), and Documents against Payment (D/P).
The current listed wholesale price for Surgical Gown Level 4, Fda510k from Medcare Healthcare Co. is $25/Bags on FOB terms from Turkey. Prices may vary depending on order volume, packaging, and destination. For the most accurate bulk quote, send a direct RFQ to Medcare Healthcare Co. through EximNext.
The supplier, Medcare Healthcare Co., has set a Minimum Order Quantity (MOQ) of 1 Bags for Surgical Gown Level 4, Fd. For sample requests or smaller trial orders, contact the supplier directly through our platform's inquiry system.
For international shipping and customs clearance, Surgical Gown Level 4, Fda510k is classified under HS Code 6210.10. Buyers should verify their local customs regulations to determine applicable import duties and taxes for this classification.
To import Surgical Gown Level 4, Fd from Turkey, negotiate shipping terms (FOB, CIF, or EXW) directly with Medcare Healthcare Co.. Ensure you have the necessary import licenses for Disposable Gowns products in your destination country.
Yes, Medcare Healthcare Co. 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.
The key specifications for Surgical Gown Level 4, Fda510k supplied by Medcare Healthcare Co. include AAMI PB70 Level 4 / ANSI/AAMI PB70, Triplex SMS (Spunbond-Meltblown-Spunbond) Polypropylene Nonwoven, and S, M, L, XL, XXL, XXXL. For a complete technical data sheet or Certificate of Analysis (COA), send an inquiry directly to the supplier through EximNext.
Medcare Healthcare Co. offers Surgical Gown Level 4, Fd with standard export packaging. Custom packaging, private labeling, and OEM/ODM options may also be available for large wholesale orders.
Surgical Gown Level 4, Fd is actively imported by buyers worldwide. Request a destination-specific CIF or CFR quote from Medcare Healthcare Co. through our platform.
Medcare Healthcare Co. maintains international quality certifications. These ensure that the Surgical Gown Level 4, Fd meets international quality, safety, and regulatory standards required for cross-border trade.
Click "Request Quotation" on this product page, specify your required quantity, preferred shipping terms, and destination country. Medcare Healthcare Co. will respond with a detailed wholesale quote including FOB pricing, lead time, and payment options.
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 Medcare Healthcare Co..
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