Section 510(k) of the Food, Drug and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k). Medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected.
http://www.fda.gov/cdrh/510k.html

Dentists and consumers have long recognized the American Dental Association (ADA) Seal of Acceptance as an important symbol of a dental product's safety and effectiveness. Participating manufacturers commit significant resources to test and market products in the Seal program.

ASTM International is one of the largest voluntary standards development organizations in the world-a trusted source for technical standards for materials, products, systems, and services. Known for their high technical quality and market relevancy, ASTM International standards have an important role in the information infrastructure that guides design, manufacturing and trade in the global economy.

It is the standards and methods used to test the gloves for medical grade that conforms to the American Standard Testing Method (ASTM).

Identification code consisting of a series of vertical bars of variable width that are scanned by a laser; printed on consumer product packages to identify the item for a computer that provides the price and registers inventory information.

Caution statement is applicable for all powdered gloves US shipment, where a statement of protein content must be added into the inner box. This will inform the user on the existence of protein.

CE Mark, or CE marking as it is officially named, is an obligatory product mark for the European market, which indicates compliance 'certification' according to the requirements formulated in the approximately 22 European 'CE Marking Directives' and subsequent European standards. Therefore, the CE mark is important for manufacturers and importers placing products in the European market.

CGSB standards are used in almost every aspect of Canadian government and are recognized in countless industries worldwide. They are one of the largest standards development and conformity assessment organizations in Canada.

Chemical compounds are used during the manufacturing of gloves, which may remain in varying amounts. Water leaching helps reduce these residues.

A process of producing powder free gloves by treating these gloves with chlorine. It also removes the first layer of protein to an acceptable level.

Cleanroom gloves area gloves used in a highly close-up environment where bacteria are at the minimal rate. All cleanroom gloves have to be sterilized.

Formers are woulds dipped into the coagulant tank to extract the protein from the previous glove dipping. This dipping are done once for every production cycle.

It is the process where chemicals are added to produce a good mixture of latex for the production of gloves.

The cornstarch is used for all powdered gloves. Cornstarch act as the “powder” for easy donning purposes.

Elongation test is one our testing method to measure the strength of our gloves. Results are taken once the gloves break when during the stretching (elongation) test.

Most allergy cases are caused by protein found in latex gloves. Therefore, it is tested that water can extract a certain class of protein. ASTM D5712 standard for testing extractable proteins using a modified Lowry Method for common determination.

Food and Drug Administration. It is the United State’s authority body that regulated approval for import of goods into the States.

It is the surveillance and detention without physical examination of surgeon’s and/or patient examination gloves. Automatic Detention program developed by the FDA to monitor and control glove products manufacturers by firms who repeatedly import non-compliance products.

Good Manufacturing Practice, a guidelines proposed by FDA to ensure quality in production of biomedical products.

Hazard Analysis and Critical Control Point (HACCP) – based food system has been introduced by FDA to monitor and control food supply into USA market by ensuring it is safe from hazardous.
http://www.cfsan.fda.giv/~lrd/bghaccp.html

Having a decreased tendency to provoke an allergic reaction

Non-medical grade gloves.

Inner is the box used for keeping the gloves in place. Every carton has 10 inners are inserted into a carton.

Irritation is caused by allergy of either later or powder from the gloves. Symptoms of irritation are rash and itchiness.

ISO is a network of the national standards institutes of 146 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. Therefore, ISO acts as a bridging organization in which a consensus can be reached on solutions that meet both the requirements of business and the broader needs of society, such as the needs of stakeholder groups like consumers and users.

Commonly, it is referring to a milky (usually whitish) fluid obtained from over 1,000 species of trees and plants. It is the most important raw material used for the production of latex gloves, natural rubber latex, which is derived from the Hevea Brasiliensis tree species found mainly in South East Asia though they originated from Brazil.

It is one of the stations in the production process of latex gloves manufacturing whereby the tank is filled with compounded latex. Once the formers go through this tank, it will pick up and form a latex layer on it.

Contain no natural rubber latex (Kindly refer to synthetic rubber)

A washing process commonly used during the glove manufacturing process using hot water to remove the protein, residue chemicals and particles from the glove.

Glove length is measured from the tip of the middle finger to the outside edge of the cuff. The normal standard for examination glove length is about 240mm , while for surgical gloves is 280mm and 300mm for household, cleanroom and 12” high risk gloves.

It is actually glove made from natural rubber latex but it is different from the standard examination gloves because its length is 12” (300mm) instead of 9” (240mm). Usually this glove is used in industrial industry. The extra length provides additional protection from unwanted and dangerous substance.

It is an indication of when and from which factory the specific gloves have been produced. Top Glove “In-House Lot Number” goes by 12 or 13 digits for record and tracing purpose. However, private lot number is still acceptable upon request.

Defects that may cause the glove to fail in its performance and lower the barrier protection. (i.e. pinhole)

Companies exporting or wishing to export to Canada medical devices of class II and above are required to have a Medical Device Licence issued by Health Canada. Effective January 1, 2003 all Canadian and Foreign manufacturers applying for a new Medical Device Licence, or applying for renewal of an existing Medical Device Licence are required to submit an ISO 13485 or ISO 13488 Certificate of Registration issued by a CMDCAS Recognized Registrar together with their application.

Defects that unlikely to reduce the usability and performance of the gloves such as discoloration or small dirt.

It is actually a measurement for the resistance of stretch, whereby the lower the modulus means the gloves is much more flexible and elastic to move thus less fatigue on the hands.

Amount of water exist in the glove, which need to be control
at the minimum to prevent discoloration of glove.

Kindly refer to Latex and Rubber.

It is a voluntary certification mark in France. NF means "Normes Françaises", French Standards.

One of the synthetic gloves that is produced from the synthetic latex of Acrylonitrile Butadiene Copolymer type, which is resistance to oil and exhibiting rubber-like characteristics.

Gloves can be categorized into medical and non-medical industry whereby the non-medical is referred to the usage in industrial industry, which is non-related to medical field some examples include; food industry, electronic and etc. The word ‘industrial’ is used interchangeable with ‘non-medical.

Examination and non-medical gloves are normally nonsterile. This means that the gloves are not subjected to gamma irradiation that kill micro-organisms.

Minute separate particle, as of a granular substance or powder.

Process which a chemical can pass through a protective film without going through pinholes, pores, or other visible openings. It’s data can be presented in two values:-
i) Breakthrough Time

•	Times observed from the start of the test to first detection of the chemical on the other side of the sample.
•	These times represent how long a glove can be expected to provide effective permeation resistance when totally immersed in the test chemical.

ii) Rate

•	The highest flow recorded for the permeating chemicals through the glove samples during a six-hour test.
•	These qualitative ratings are comparisons of permeation rates to each other.

The most important aspect in assessing the standard of the gloves. Pinholes are tiny holes in gloves that are detected using air pump or water tight test.

Disposable polyethylene or PE gloves are made with materials approved by USDA, provide protection from organic vapors, dusts and mists thus making them a smart choice for any food service application. All of the gloves are powder free. Our polyethylene gloves are printed with an embossed finish on both sides to improve grip and is ambidextrous to fit either hand.

A chemical compound whose molecule is formed from many repeated units of one or more compounds.

It is a polyvinyl resin used extensively in the manufacturing of medical devices such as gloves and it also used as a rubber substitute. Kindly refer to Vinyl Gloves.

Due to the natural sticky characteristic of latex, powder is used as the means to prevent the gloves from sticking together and ease of donning. Donning powder on gloves is composed of cornstarch (USP absorbable dusting powder).

The technology to prevent stickiness of gloves by avoiding powder usage completely by going through chlorination or polymer coating process.

Pre-Leaching

Kindly refer to Leaching.

All natural rubber latex products contain protein. For latex gloves, it is the measurement of total protein regardless of allergenic content. The ASTM D5712 standard is using the test method in the Modified Lowry assay for analysis of aqueous Extractable Protein Natural Rubber.

All planned and systematic actions required to provide adequate confidence that the glove satisfy the necessary needs. Top Glove’s gloves are consistently tested to ensure that it meet the Acceptable Quality Level (AQL) before it is exported.

It measured the excess powder beyond what is required.Currently the test measured total powder extractable in water.

An elastic substance produces from latex of Hevea Braziliensis (rubber tree).

The expiry date for the usage of the gloves. For Powdered and Powder Free Gloves show a shelf life of 5-years.

Referring to the flute of the carton box. Single wall mean that the layer in-between for the carton is only one layer.

The Standards and Industrial Research Institute of Malaysia (SIRIM) is a national multi-disciplinary research and development agency under the Ministry of Science, Technology and the Environment. Established in 1975 under the SIRIM (incorporation) Act 157, SIRIM was set-up to assist companies solve technical problems through the use of technology and help their business growth.

Glove size is determined by measuring the circumference of the hand around the palm area with a tape measure. The usual size standard for examination gloves are of XS – XL while surgical gloves are of 6.5 – 8.5.

Slurry dipping tank consisting of solution of corn-starch to prevent gloves sticking inside.

The Standard Malaysian Glove (SMG) is produced by glove manufacturers under certification by the Malaysian Rubber Board (MRB), with a quality assurance in line with the technical specifications of the American Society for Testing and Materials (ASTM) and the U.S. Food and Drug Administration (FDA), In addition, SMG-certified manufacturers must have a Quality Management System equivalent to ISO 9001:2000.

Even surface of the gloves by using smooth surface former.

The Thai province of Songkhla is located in the southern Peninsula Malaysia to the south and the gulf of Thailand to the east. Top Glove’s Factory 7 is located in city of Hatyai, which is located in this Songkhla province.

Sterile gloves are those gloves that have gone through sterilization process to assure that it is without any living organisms.

Using Gamma Irradiation to eliminate all microbial life, including highly resistant bacterial spores.

The manual or automated process of removing gloves from the formers, where they are turned inside out. Top Glove‘s latex examination gloves are stripped by fully automated stripping machine.

This glove is meant for the usage in surgery room for the surgery operation. Need to be sterilized and it is hand-specific to prevent hand fatigue during surgery process.

Alternative to natural rubber. It is produced by chemical synthesis. Type of synthetic gloves produced by Top Glove is nitrile and vinyl gloves.

This is an important aspect in selecting glove because the tactile sensitivity of the user while wearing the glove can ensure good performance. Therefore, the thinner the glove is, the better the tactile sensitivity it provide.

It is a measurement of the stretch required to break the glove material. Gloves without good vulcanized process tend to have higher tensile strength.

Textured surface on the glove, which is caused by the uneven surface of the formers. Textured gloves will provide better grip.

The Therapeutic Goods Administration (TGA) is a unit of the Australian Government Department of Health and Ageing. The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances including medical device such as gloves.

Measurement of glove surface depth protecting skin from exposure to elements. It is measured on a single wall using a micrometer over several parts of the glove, typically at the cuff, the mid-palm and the finger sections.

Tumbling process removes excessive powder on the glove.

USP

United States Pharmacopeia. A non-profit organization that develop quality standards for medical device.

Vinyl Glove

Polyvinyl chloride (PVC) glove is a type of synthetic gloves, which is used as an alternative to natural rubber latex examination glove.

Vulcanizing

It is curing process, whereby the latex particles are modified by adding in chemicals to it. In particular, the sulfur atoms are chained with the rubber molecules to form a cross-link that strengths the physical properties of the rubber. Without vulcanization, rubber will tear and melt easily.

Water Tight Test

A test to determine the AQL level of an examination gloves by checking on the pinholes rate of the particular gloves after filling up the gloves with 1000ml water and then check for any leakage in 2 minutes time.

Weight

Gloves are usually weighted in grams. The calculation of gloves in one inner box is usually based on weight rather than 100pieces counting.

Width

The width of glove is usually measured across the palm, from just above the thumb to just below the small finger.

Zhangjiagang

Top Glove’s Factory 8 in China is located at this town, Zhangjiagang, which is nearly 200km or about two and half hours drive from Shanghai, China