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The FDA‑approved QKR disposable face mask is constructed from a non‑woven polypropylene laminate that combines spunbond outer layers with a melt‑blown filtration core. Material composition is a blend of spunbond and melt‑blown polypropylene, providing both structural strength and fine particle capture. The mask meets Class II medical device classification, holding FDA registration and CE conformity, which confirms its suitability for clinical environments. Each mask is supplied in standard adult size and packaged in boxes of 50 units, ready for bulk handling.
Typical bacterial filtration efficiency for this mask type reaches 95 % when tested according to ASTM F2100, and breathability is measured at a pressure drop around 5 mm H₂O cm⁻², offering comfort during extended wear. The three‑layer construction - two spunbond outer layers and a central melt‑blown filter - delivers a balanced combination of filtration and airflow. Standard industry practice includes compliance with EN 14683 and ISO 22609 testing, which are frequently applied to similar disposable surgical masks. Weight per mask is roughly 3 g, and the product has a typical shelf life of three years when stored in a dry environment.
Healthcare facilities, clinics and occupational safety programmes source this mask for its reliable barrier protection and regulatory compliance. Suppliers generally allow flexible order quantities, making it suitable for both small clinic orders and large‑scale hospital procurement. Shipping is often arranged under FOB or CIF terms, with packaging designed to preserve mask integrity; buyers should verify incoterms, payment method and any required import documentation with the supplier.
| Material | Non‑woven polypropylene (spunbond + meltblown) |
| FDA Classification | Class II medical device (approved) |
| CE Compliance | Yes (typical) |
| Bacterial Filtration Efficiency | Typical 95 % (ASTM F2100) |
| Pressure Drop (breathability) | Typical 5 mm H₂O cm⁻² (typical) |
| Layers | Three (two spunbond outer, one meltblown core) |
| Size | Standard adult (typical) |
| Weight per mask | Typical 3 g |
| Packaging | 50 masks per box, export‑ready cartons (typical) |
| Shelf Life | Typical 3 years when stored dry |
Opera Medical Products is listed with a harbor trust tier, indicating a verified business entity operating in the United States. The public profile does not disclose a detailed street address, only that the company is based in the United States, and its response rate is recorded as 0 % with an average response time of 0 hours, which may affect communication speed.
The catalogue focuses on disposable medical protective equipment, highlighted by the FDA‑approved QKR face mask. The listing does not state minimum order quantities, lead times or pricing, so prospective buyers should request those specifics directly. Additional certifications such as ISO 13485 can be queried if required for your quality management system.
The FDA Approved QKR Disposable Face Mask is a three-layer nonwoven surgical mask engineered for medical and general protective use. Featuring a two-layer spunbond outer construction with a meltblown filtration core, this mask provides effective bacterial filtration efficiency. Suitable for hospitals, clinics, and general public use, it is packaged in standard 50-piece boxes with export-ready cartons. As a Class II medical device, it meets FDA registration and CE compliance standards, making it ideal for import/export trade channels serving healthcare procurement chains.
| 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 |
When initiating a purchase, obtain the FDA registration number and CE Declaration of Conformity to verify that the mask complies with the required medical device regulations. Request the latest bacterial filtration efficiency test report and a material safety data sheet that details the polypropylene composition, ensuring the product matches your performance criteria. Confirm that the supplier can provide a certificate of compliance for the specific batch you intend to import.
Logistics for disposable masks commonly use sea or air freight under FOB or CIF terms; however, the exact incoterm, freight forwarder and estimated transit time must be agreed with the supplier. Payment arrangements such as telegraphic transfer or letter of credit are typical in bulk medical supplies, but the buyer should settle the payment schedule and any advance deposit before production. Lead‑time information is not disclosed, so ask for a detailed production schedule to align with your procurement plan.
To safeguard quality, arrange a third‑party pre‑shipment inspection that checks mask dimensions, weight and BFE performance against the agreed specifications. Request a full test report and a certificate of origin to accompany the shipment, facilitating customs clearance in the destination country. Maintaining thorough documentation, including FDA and CE certificates, will help ensure smooth import procedures and compliance with local health authority requirements.
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When sourcing Fda Approved Qkr Disposable Face Mask for your business, securing the right balance of quality and cost is essential. Opera Medical Products, a verified supplier based in United States, offers this product with key specifications including Surgical/Medical Grade, FDA Registered Class II Device, Three-Layer Nonwoven: 2 Spunbond Polypropylene Outer Layers + 1 Meltblown Polypropylene Filtration Core, and 17.5 cm x 9.5 cm (Standard Adult Size). By purchasing directly from the manufacturer or authorized exporter, buyers can negotiate favorable FOB prices starting at $0.59/Bags and manage bulk orders with a minimum order quantity (MOQ) of 1 Bags. This product is actively traded under HS Code 6307.90, making it a staple in the Disposable Face Mask sector with strong demand from importing countries worldwide.
Importing Fda Approved Qkr Disposab requires careful attention to shipping logistics, customs compliance, and secure payment terms. Opera Medical Products 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 6307.90 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 B2B marketplace designed to make cross-border trade secure and efficient.
Finding trustworthy partners is the foundation of successful importing. The supplier of this Fda Approved Qkr Disposab 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 Face Mask category and connect with top-tier exporters on our comprehensive global B2B marketplace. Start your sourcing journey today.
Importing Fda Approved Qkr Disposab 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 6307.90 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 Fda Approved Qkr Disposable Face Mask from Opera Medical Products is $0.59/Bags on FOB terms from United States. Prices may vary depending on order volume, packaging, and destination. For the most accurate bulk quote, send a direct RFQ to Opera Medical Products through EximNext.
The supplier, Opera Medical Products, has set a Minimum Order Quantity (MOQ) of 1 Bags for Fda Approved Qkr Disposab. For sample requests or smaller trial orders, contact the supplier directly through our platform's inquiry system.
For international shipping and customs clearance, Fda Approved Qkr Disposable Face Mask is classified under HS Code 6307.90. Buyers should verify their local customs regulations to determine applicable import duties and taxes for this classification.
To import Fda Approved Qkr Disposab from United States, negotiate shipping terms (FOB, CIF, or EXW) directly with Opera Medical Products. Ensure you have the necessary import licenses for Disposable Face Mask products in your destination country.
Yes, Opera Medical Products 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 Fda Approved Qkr Disposable Face Mask supplied by Opera Medical Products include Surgical/Medical Grade, FDA Registered Class II Device, Three-Layer Nonwoven: 2 Spunbond Polypropylene Outer Layers + 1 Meltblown Polypropylene Filtration Core, and 17.5 cm x 9.5 cm (Standard Adult Size). For a complete technical data sheet or Certificate of Analysis (COA), send an inquiry directly to the supplier through EximNext.
Opera Medical Products offers Fda Approved Qkr Disposab with standard export packaging. Custom packaging, private labeling, and OEM/ODM options may also be available for large wholesale orders.
Fda Approved Qkr Disposab is actively imported by buyers worldwide. Request a destination-specific CIF or CFR quote from Opera Medical Products through our platform.
Opera Medical Products maintains international quality certifications. These ensure that the Fda Approved Qkr Disposab 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. Opera Medical Products 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 Opera Medical Products.
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