Quality Overview

Quality in gloves cannot always be visually verified, nor should quality be solely exemplified by the fit, feel or don ability of a glove. A gloves primary goal is to protect an end user from exposure; therefore the most critical quality aspect of a glove is whether it provides an intact barrier, thus, no pinholes.

Performance in the field for the wearer is crucial, including fit and feel, but interestingly enough, what can’t be seen with the naked eye will produce the most significant impact to the wearer’s safety. In order for the user to fully understand what best exemplifies quality in a glove, it is important to understand:

• where and how gloves are manufactured
• the regulatory agencies that oversee their import
• how manufacturers and importers set specifications
• test standards, sampling, and inspection
• 3rd party testing and protocols
• the various loopholes that can impact the user in the field

Where are gloves manufactured?

The majority of gloves are manufactured in Malaysia, Thailand, China, and throughout the Pacific Rim where the raw materials are indigenous to the land, hence where the manufacturing hub of the glove industry initiated. They are imported into the United States through importers, who subsequently sell them to end users through a distribution channel, or as is the case of FirstLine Gloves, directly to the end user (factory direct.) Importers may own factories, have partnerships, or simply broker gloves from a variety of glove manufacturers who offer the most competitive price.

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 operations, from small makeshift plants, to sophisticated factories using state of the art glove manufacturing 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 by the FDA. 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 annually, only being audited once or twice by the FDA for watertight failures, the most common defect in gloves.

Should the FDA fail a lot of gloves, the manufacturer will 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 is implemented and monitored by 510K number, by glove category, i.e. surgical or exam, and by manufacturer, resulting in every product imported potentially being inspected.

Who monitors the ongoing quality of a glove?

It is really a combination of the manufacturer, importer, FDA, and, of course, the customer. Quality starts on the production line, and hence the manufacturer plays a key role in providing consistent quality with every shipment, or lot of gloves produced.

Millions of gloves can be manufactured on a glove line weekly, and manufacturers’ profitability is based upon capacity, line productivity and efficiency, whereby running 24/7 produces optimum profits. Therefore, it is possible for manufacturers to ship billions of gloves per year.

First, in order to ship a medical glove, a manufacturer must receive a 510K Class 1 pre-market medical device registration from the FDA. This registration is acquired by the manufacturer submitting samples to a FDA approved, 3rd party, independent test laboratory.  Testing includes a multitude of tests, including testing to ASTM standards, as well as FDA specific tests for sensitivity. This data is subsequently submitted to the FDA for review and approval. Because samples for this testing are submitted by the manufacturer, and no FDA audit is conducted, the objectivity of the data submitted to the FDA could be considered subjective.

Once a 510K number is received, a manufacturer is required to conduct ongoing routine testing of the product, again, subjective data. Of utmost importance to the consumer is how do they know if their order of 1000 gloves is of acceptable quality? Who is guaranteeing the consumer that the one case, or 100 cases that are purchased, have in fact been certified or tested utilizing an objective reliable source?

There are NO procedures, policies or mandates that require shipments be tested routinely by a 3rd party. Hence, the consumer is subject to the manufacturer being forthcoming about the quality of the product. One could, and ultimately should ask…………what happens to the millions of gloves that do not pass medical standards? What system is in place to ensure seconds or defective gloves do not enter the United States?

Who can test the gloves?

Quality should be monitored on line at the factory and in house testing performed throughout the process by the manufacturer. In addition, 3rd party testing can be requested by the buyer (importer) to ensure the buyers specifications are adhered to.

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

Where to test, Malaysia 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.

Most importantly, why would an importer incur thousands of dollars in shipping costs to import product that has not been determined as compliant to specification.

What sets FirstLine Gloves apart from other importers?

FirstLine Gloves 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 are not “glove brokers” and 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 because a manufacturer may not control the lot size to a specific quantity. As an example, current mandated  sampling for any lot over 500,000 gloves will have 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 Gloves lot control quantities for each specific glove:

Crew Blue < 600,000
First Defense < 600,000 Virepel < 600,000
Get a Grip < 900,000
Hands On < 900,000
Intercept Elite < 1,000,000
Intercept < 900,000
Touch N Go < 900,000
Flextreme < 900,000
All Hands < 900,000

What is SPC?

Statistical Process Control, is a methodology introduced by Walter Shewhart in the 1920’s and was successfully demonstrated when Honda Motor Company utilized this methodology in the manufacturing of their cars in the late 1970’s. It is based on the idea that a process has one or more measurable attributes, natural also referred to as common, or and assignable, also known as special causes. If the observed variability of the attributes of a process is within the range of variability from natural causes, the process is said to be under statistical control. In short, by applying these methods to a process constantly (not just when problems appear), it is possible to reign a process into a state of control without deviation. Properly done it can result in significant improvement to the product.

Necessary for SPC to be successful is process monitoring which must be done by objective testing, or 3rd party testing. These results are what allow the manufacturing team to define and tighten the tolerances, thus continually improving the process and ultimately the quality.

As a customer finds a potential defect and reports it to FirstLine Gloves, we review test results and 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 failed or 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.

To verify that we are not manufacturing gloves in non audited factories, a requirement of the NFPA 1999 standard, we link every shipment to a purchase order number, referenced on each and every 3rd party test report. These reports are readily available upon request.

Test data guarantees the customer that our gloves meet specifications, quality will be consistent from shipment to shipment, gloves are never produced thinner than specs, nor individual boxes packed with less than the labeled count. These deviations provide manufacturers with the ability to quickly gain back shrinking margins in a very competitive industry. Consider the following:

• 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 or received in previous purchases?

Samples presented up front in a bid or evaluation process may appear of superior quality, but once into the supply agreement, the customer experiences quality issues.

Summation

FirstLine Gloves is the first supplier to design gloves solely intended for use in an EMS application. Our companies exclusive focus is the EMS market, thus our formulations are intended to provide strength and durability first, needed for critical protection in a hi risk environment.

Because we recognized the uniqueness and challenges for the first responder, FirstLine Gloves implemented quality manufacturing processes that far surpassed criteria required by either NFPA or FDA standards. FirstLine’s stringent tolerances redefined the glove quality and our commitment to educating the end user has enabled us to become the preferred supplier to the EMS market today.

As always, we welcome customer feedback and hope this information has provided the education necessary to purchase products utilizing a quality driven process.