Quality Center

Quality in gloves cannot always be visually verified, nor is quality best exemplified by the fit, feel or don ability of a glove.

Although the performance in the field for the wearer is crucial, interestingly enough, what can't be seen with the naked eye will produce the most significant impact to the wearer's safety.

Where are gloves manufactured?

The majority of gloves are manufactured in Malaysia and Thailand, and then imported in through distribution companies like FirstLine. Some distribution companies own their own factories, while other distributors shop for the best deal.

It is most important to understand that there are hundreds of glove manufacturer's throughout the Pacific Rim. There is a wide range of business type, from Mom and Pop operations, to very sophisticated factories using state of the art manufacturing glove lines and processes.

How does product enter the United States?

Importers are only required to submit an invoice, packing list and bill of lading to a custom's broker for import clearance into the United States. For each glove type, a 510K number is used to monitor imports. Each 510K number can be sampled quarterly by the FDA, however, it is important to remember that a manufacturer may ship hundreds of containers of gloves into the United States against each 510K number, only being audited once or twice by the FDA for watertight failures and packaging labeling requirements.

Should the FDA fail a lot of gloves, the manufacturer can be put on auto detention, a mandatory sampling system whereby, a designated number of shipments of gloves will be automatically detained and inspected. If more shipments fail, then the level of auto detention intensifies, requiring more containers be tested to more stringent quality levels. Auto detention can be per 510K number, by glove category, i.e. surgical or exam, or by manufacturer, meaning every product shipped in can be inspected.

Who monitor's the ongoing quality of a glove?

It is really a combination of the manufacturer, importer, FDA, and, of course, the customer.

Millions of gloves can be produced on a glove line weekly, and manufacturers can often have several lines running full time, therefore, it is possible for manufacturers to ship billions of gloves per year.

First, in order to ship a medical glove, a manufacturer must have extensive testing done by third party independent laboratories in order to receive a 510K number from the FDA, which allows sales into the medical market.

Once a 510K number is received, a manufacturer is required to conduct ongoing routine testing of the product. So, how does the consumer know if their order of 1000 gloves is of acceptable quality? Unfortunately, the testing required is unmonitored and a manufacturer is on the "honor system."

More importantly, my concern has always been that once production is completed, and the glove is found of poor quality, does every manufacturer discard the low quality product, and lose potential revenue in the tens of thousands of dollars?

Who can test the gloves?

Quality can be monitored on line at the factory and checked periodically throughout the process by the manufacturer conducting routine in house testing, or testing can be performed by a 3rd party independent test laboratory.

There are many independent test laboratories located in both Malaysia and the United States that conduct 3rd party testing.

Where to test, Offshore Factory or the United States?

If testing is conducted after receipt of product by the importer in the United States, product has more than likely already entered the marketplace, since it is highly unlikely that the importer would quarantine the already paid for product while testing is conducted.

Secondly, individual lot testing is better conducted on the product before a container is shipped from overseas. Since shipping a container is very costly, it would be unlikely an importer would discard product if it failed testing in the United States after arrival.

What sets FirstLine apart from other importers?

FirstLine partners with a limited number of manufacturers who meet our own internal design and quality requirements, and who are audited quarterly by Underwriter's Laboratories for NFPA compliance. We do not shop around for the "best deal," nor do we import from factories that are not enrolled in the NFPA quarterly audit program.

Moreover, we control the number of pieces produced in a lot. This is critical in that a manufacturer may set the lot size to any quantity. As an example, at current mandated ASTM sampling, any lot over 500,000 gloves has only 500 pieces pulled for watertight testing. Therefore, whether you manufacture 600,000 gloves in a lot, or 5,000,000 gloves in a lot, a manufacturer may still only pull 500 pieces for testing. Thus, testing is more representative of overall lot quality when the lot size is controlled to a smaller number.

Listed below are FirstLine lot controls for each specific glove:

Gladiator < 600,000 gloves
First Defense < 600,000 gloves
Virepel < 600,000 gloves
Get A Grip < 700,000 gloves
Intercept < 900,000 gloves
Touch & Go < 900,000 gloves

What is SPC?

SPC, Statistical Process Control, is the process whereby testing is required on each and every lot. By compiling data, charting on line process tolerances, monitoring the process to batches, (a subset of a lot that is linked to the most critical part of the process and the incoming lot number of raw material), SPC strives to achieve zero defect manufacturing. SPC is a process that over time produces consistent quality product on every lot manufactured, thereby reducing failures in the field, and improving performance, and thus customer satisfaction.

As a customer finds a potential problem and reports it to FirstLine, we review the on line process data at the factory. Quality Assurance subsequently tightens the process tolerance, resulting in improved quality gloves. Over time, defects that may be acceptable to process lines without such controls, can be completely eliminated at factories utilizing SPC.

Eliminating the Loopholes

Since a manufacturer may not necessarily release poor test results from their own laboratory, FirstLine contracts with a third party independent test lab and inspector to test each lot manufactured. At completion of packaging, the lot of gloves is quarantined at the factory, a random sampling is taken, testing conducted, and shipment released only when pass results are obtained.

We link every shipment to a purchase order number, and are happy to provide copies of documents that substantiate your gloves were produced at a UL approved factory.

On our website, we post each and every 3rd party independent test report, for every customer to review. This guarantees the customer that our gloves are never produced thinner than specs, nor individual boxes packed with less than the labeled count, both ways that many manufacturer's gain back shrinking margins in a very competitive industry.

• Let's face it, when was the last time you counted the number of gloves in a box to ensure you received 500 gloves in your case, rather than 400?
  
  
• When was the last time you measured the thickness of your glove, to ensure you received the same glove as represented in a literature sheet?
  
  
• Samples presented up front in a bid may appear quite thick, but once into the contract, suddenly gloves start breaking. Do you measure individual lots to ensure your glove thickness has not been reduced?

Challenge us.
We hold ourselves accountable so that you, the customer, can spend your
time treating the patient, rather than curing a glove problem.

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