Is your Supply Chain Safe, after all most of your gloves are imported from China?

All of Handgards' products, both domestic and imported, are held to the same standards and are verified by both our 3rd party audits and our Procurement, Quality and Regulatory Compliance departments. Handgards strongly believes in processes and procedures that are persistently audited by 3rd party Companies such as: AIB (American Institute of Baking), NSF-Cook and Thurber, and SGS.

Our commitment to Food Safety and product quality is evidenced by the programs that Handgards has implemented and improved upon; our commitment to employee training is second to none and great emphasis is placed on Good Manufacturing Practices, Hazard Analysis and Critical Control Points, and Quality, as well as Food Safety and Security.

Our New Imported Supply Chain Programs include initial and periodic testing and/or evaluation, and random unannounced inspections by 3rd party auditors. Also, several members of our Import Procurements team audits our overseas facilities 3 times per year, and we maintain a 2 full time employees in Hong Kong that do unannounced audits on our behalf.

 

What do your audits focus on?

First they focus on FDA Compliance; Handgards products meet or exceed all applicable FDA food contact standards in quality for toughness, appearance and protection. All Handgards gloves, domestic and import follow FDA regulations regarding food contact. Second, GMP Compliance; Handgards follows “Current Good Manufacturing Practices in Manufacturing, Processing, Packing or Holding Human Food”. Last, but certainly not least, Food Safety and Security such as Quality, Packaging, and Social Compliance audits

 

What are the differences between food-service gloves and examination (exam) gloves?

EXAMINATION GLOVES:

Examination or Medical-grade gloves differ from Industrial grade gloves in that they are regulated by the Food and Drug Administration (FDA), and are accepted for use by doctors, dentists, labs, or any other application requiring a specific barrier to blood or infectious agents. These gloves are non-surgical, non-sterile, and are regulated by stringent FDA requirements requiring specific production and quality control standards (detailed in FDA 510(k) Class II Medical Device Listing).

GENERAL PURPOSE GLOVES:

General-purpose gloves are accepted (but not “approved” or “certified”) for use in foodservice, industrial or any other application that does not require a specific barrier to blood or infectious agents. This is the most common glove found in the marketplace and popular uses include foodservice, packaging, automotive, painting and health & beauty.

General-purpose gloves are, in fact, exam grade gloves that did not pass FDA mandated quality control tests (e.g. FDA water leak testing). While no one intentionally manufactures a general-purpose glove, our gloves are manufactured as medical grade gloves, yet do not undergo the final steps of the FDA testing process. This give Handgards gloves a near-exam level of quality. This process of taking near-exam quality gloves off the medical grade lines is sometimes referred to as “off-line” production. This means that the gloves are “stripped” from the medical grade production lines, then “packed” just before they undergo the final FDA testing process. What differentiates the gloves is a higher “AQL” (acceptable Quality Level-FDA benchmark for rejection rates) than “B” or “C” grade gloves. Handgards gloves have an AQL of 2.5% - 4.0%, meaning a medical grade rejection rate of only 2 – 4 gloves per hundred.

Does the USDA or FDA officially certify gloves?

No, neither the FDA nor the USDA officially “certifies” gloves for entry into the United States. What the FDA does require, however, is for manufacturers of all examination (medical grade) gloves to have 510(k) device listings on file with the agency. This means, that the manufacturer has been tested and approved to manufacture gloves for medical use. The FDA conducts random testing on containers of examination gloves and general purpose gloves as they enter the U.S.

What is Microban® Antimicrobial Protection?

The Microban Products Company develops custom engineered antimicrobial solutions that are built-in to products during the manufacturing process to provide effective antimicrobial protection for the useful life of the product. Microban antimicrobial protection can be infused into all types of plastics and synthetics, in industrial, medical and consumer products, providing them with resistance to the growth of bacteria, molds and mildew (that can cause stains, odors and product degradation).

Microban is not a temporary “treatment” or a non-durable finish. Unlike surface coatings, it won’t wash off or wear away. Microban protection is incorporated directly into the polymer’s molecular structure during the manufacturing process and does not alter the products physical properties. Once production has been completed, the polymer itself acts as a reservoir for the Microban ingredient. Microban protection is odorless, tasteless, colorless and has a proven history of safe use. Upon contact with bacteria, the Microban ingredient penetrates the bacteria’s cell wall and inhibits its ability to function, grow and produce.