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Certifications and Standards (FDA Links)

Click here for links to the products as listed on the FDA website.

Surgical Mask
Model Number EK-JK-KZ-01
FDA Listing

Face Shield
Model Number EK-JK-FSXT02
FDA Listing

KN95 Mask, Model Number EK-JK-KZ-04
FDA Listing

Protective Clothing (Protective Class I and II)
Model Numbers EK-JK-FFH-01, EK-JK-FFH-02, EK-JK-FFH-03
FDA Listing

Examination Gloves
Model Numbers EK-JK-ST-01, EK-JK-ST-02
FDA Listing

Shipping Time

Products listed, as of today, are available and ready for shipment. The capacities of the manufacturers we’re working with greatly exceed the quantity of product being exported. Speed to delivery is a function of shipping companies as well as governmental inspection and approval processes (both abroad and within the US).

With regard to delivery, yes, there are things beyond our control and we’ll always make the customer aware of that but, more importantly, we will not mislead our customer. In China, the recent addition of in-plant inspectors added 3-4 days to all suppliers’ lead times. That additional lag has already been accounted for and is reflected in our product schedules.

In these very turbulent times, we highly recommend a “buyer beware” mindset. Promises of product delivery in “just a few days” are almost never met. Recently we were told the story of a $2M order that was withdrawn because a competitor had promised a shorter lead time. It didn’t turn out as promised and the order was reinstated with the original supplier, ultimately causing additional, unnecessary delay.

We know where our products are in the supply chain, and we will always do our very best to provide a delivery date as based on facts, not “hope”. The good news is we do make every attempt to anticipate upcoming need, and therefore almost always have product already in transit. For our customers, that means we often deliver earlier than expected.

Customer

Assuring exported product is properly accredited led to implementing a heightened inspection criterion, including, among other things, the stationing of inspectors in the very facilities producing the products we procure (see Product Quality).

Both the manufacturer and U.S. representative of the manufacturers are listed by name on the FDA accreditations. Click here for links to the products as listed on the FDA website.

There is a lot more in the way of protection and/or recourse available to a buyer. In the placement of large, bulk orders, we are certainly protecting our company, and in doing so that ultimately means protecting our customers.

Product Quality

On April 10th, 2020, restrictions were tightened on the export of masks and other personal protective equipment.

For example in China, these new regulations included verification by Chinese government inspectors, stationed in the manufacturing facilities, who authorize and identify product leaving the facilities. At the export site, product that carries the factory inspection certification must additionally be verified for export to ensure compliance with the regulations of the destination country. Once stateside, the product must go through US customs before it is once again freed for shipment to the destination.

It should be noted the in-plant inspections immediately increased all suppliers’ lead times by 3 to 4 days. The inspections initially created a logjam, but as processes are improving, we expect to see lead times will return to the previous.