Industry partners and standards 

Listed below are all agencies that FirstLine Gloves associates, utilizes, partners, or complies with. The information below has been compiled from the various organizations website home pages. In addition, we have listed all relevant standards.

Click on the organizations below for more information.

ISO – International Organization for Standardization

ISO is the world’s leading developer of International Standards. ISO standards specify the requirements for state-of-the-art products, services, processes, materials and systems, and for good conformity assessment, managerial and organizational practice. ISO standards are designed to be implemented worldwide.  www.iso.org 

For more information about ISO, follow this link: http://www.iso.org/iso/isoinbrief_2006-en.pdf

ISO 9001:2008 Quality Management System - Requirements

ISO 9001:2008 specifies requirements for a quality management system where an organization:

1. needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
2. aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to ISO 9001:2008 are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.
http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=46486

ISO 13485:2003 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.
If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.
The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.
http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=36786

NFPA – National Fire Protection Association

The world's leading advocate of fire prevention and an authoritative source on public safety, NFPA develops, publishes, and disseminates more than 300 consensus codes and standards intended to minimize the possibility and effects of fire and other risks. The mission of the international nonprofit NFPA, established in 1896, is to reduce the worldwide burden of fire and other hazards on the quality of life by providing and advocating consensus codes and standards, research, training, and education.  www.nfpa.org

NFPA 1999:2008

This standard shall specify the minimum documentation, design, performance, testing, and certification requirements for new single-use and new multiple-use emergency medical protective clothing, including garments, gloves, footwear, and face protection devices, used by fire and emergency services personnel during emergency medical operations. 1.1.2* This standard shall not be interpreted as providing criteria for protection from radiological agents, from hazardous chemicals, from flammable or explosive atmospheres, or from thermal hazards associated with fire fighting. 1.1.3* This standard shall not be interpreted as providing criteria for protection from blood and body fluid-borne pathogens that are airborne. 1.1.4 This standard shall not be interpreted as providing criteria for respiratory protection. 1.1.5 This standard shall not be interpreted as providing criteria for protection from chemical and biological terrorism agents. 1.1.6 Certification of emergency medical garments, emergency medical examination gloves, emergency medical work gloves, emergency medical footwear, emergency medical footwear covers, or emergency medical face protection devices, or cleaning gloves to the requirements of this standard shall not preclude certification to additional appropriate standards where the garments, gloves, footwear, or face protection devices meet all applicable requirements of each standard. 1.1.7 This standard shall not be construed as addressing all of the safety concerns, if any, associated with its use. It shall be the responsibility of the persons and organizations that use this standard to establish safety and health practices and determine the applicability of regulatory limitations prior to use of this standard. 1.1.8 Nothing herein shall restrict any jurisdiction or manufacturer from exceeding these minimum requirements.

FDA – Food and Drug Administration CDRH

The FDA’s Center for Devices and Radiological Health (CDRH) insures that new medical devices are safe and effective before they are marketed. www.fda.gov

510K Class 1 Medical Device Registration

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) . It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, 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. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.

SBA – Small Business Status Certification through the State of California

The U.S. Small Business Administration (SBA) was created in 1953 as an independent agency of the federal government to aid, counsel, assist and protect the interests of small business concerns, to preserve free competitive enterprise and to maintain and strengthen the overall economy of our nation.  www.sba.gov

WBENC – Woman Business Enterprise National Council

The WBENC certification for women-owned businesses is one of the most widely recognized and respected certifications in the nation. Accepted by thousands of corporations within the country and a number of federal and government agencies, your WBENC certification will be an important marketing tool for expanding your company's visibility among decision makers in corporate supply chain diversity and procurement. www.wbenc.org

OSHA – Occupational Health and Safety Administration

Congress created OSHA under the Occupational Safety and Health Act, which was signed by President Richard M. Nixon on December 29, 1970. OSHA's mission is to prevent work-related injuries, illnesses, and deaths by developing standards, conducting inspections, and enforcing those standards.  www.osha.gov

NIOSH - The National Institute for Occupational Safety and Health

The National Institute for Occupational Safety and Health (NIOSH) is the federal agency responsible for conducting research and making recommendations for the prevention of work-related injury and illness. NIOSH is part of the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services.
NIOSH was established by the Occupational Safety and Health Act of 1970 which also established the Occupational Safety and Health Administration (OSHA). Although NIOSH and OSHA were created by the same Act of Congress, they are two distinct agencies with separate responsibilities. NIOSH is in the U.S. Department of Health and Human Services and is a research agency. OSHA is in the U.S. Department of Labor and is responsible for creating and enforcing workplace safety and health regulations. NIOSH and OSHA often work together toward the common goal of protecting worker safety and health.  www.cdc.gov/niosh

ASTM – American Society for Testing and Materials

ASTM International is one of the largest voluntary standards development organizations in the world. They have published all relevant test standards used today in glove testing and certification throughout the world, recognized by the FDA, UL and SEI.

The following ASTM standards, are the primary standards associated with glove testing, either conducted by the FDA in accordance with ASTM guidelines, or the NFPA in accordance with NFPA 1999-2008 guidelines.  http://www.astm.org/

ASTM D6319 – Standard Specification for Nitrile Examination Gloves

1. Scope
1.1 This specification covers certain requirements for nitrile rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures.
1.2 This specification covers nitrile rubber examination gloves that fit either hand, paired gloves, and gloves by size. It also provides for packaged sterile or nonsterile or bulk nonsterile
nitrile rubber examination gloves.

ASTM D3578 – Standard Specification for Rubber Examination Gloves

1. Scope
1.1 This specification covers certain requirements for natural rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. It also covers natural rubber gloves used in handling contaminated medical material.
1.2 This specification provides for natural rubber gloves that fit either hand, paired gloves, and gloves by size. It also provides for packaged sterile natural rubber gloves and packaged or bulk non sterile natural rubber gloves.

ASTM D3577 – Standard Specification for Rubber Surgical Gloves

1. Scope
1.1 This specification covers certain requirements for packaged sterile rubber surgical gloves used in conducting surgical procedures.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

ASTM D412 – Vulcanized Rubber and Thermoplastic Elastomers – Tension 1

1. Scope
1.1 These test methods cover procedures used to evaluate the tensile (tension) properties of vulcanized thermoset rubbers and thermoplastic elastomers.

ASTM D573 – Standard Test Method for Rubber – Deterioration in an Air Oven

1. Scope
1.1 This test method covers a procedure to determine the influence of elevated temperature on the physical properties of vulcanized rubber.

ASTM F1671 – Standard Test Method for Bacteriophage penetration Resistance on Whole Gloves

1. Scope
1.1 This test method is used to measure the resistance of materials used in protective clothing to penetration by Bloodborne pathogens using a surrogate microbe under conditions of
continuous liquid contact. Protective clothing material pass/fail determinations are based on the detection of viral penetration.

ASTM F1342 – Standard Test Method for Protective Clothing Material Resistance to Puncture

1. Scope
1.1 This test method determines the puncture resistance of a protective clothing material specimen by measuring the force required to cause a pointed puncture probe to penetrate through the specimen.

ASTM D5151 – Standard Test Method for Detection of Holes in Medical Gloves

1. Scope
1.1 This test method covers the detection of holes in medical gloves.
1.2 This test method is limited to the detection of holes that allow water leakage under the conditions of the test.
1.3 The smallest hole size that will allow water leakage in a medical glove has not been determined and is beyond the scope of this test method.

UL – Underwriters Laboratories

Underwriters Laboratories Inc. (UL) is an independent product safety certification organization that has been testing products and writing Standards for Safety for over a century. UL evaluates more than 19,000 types of products, components, materials and systems annually with 21 billion UL Marks appearing on 72,000 manufacturers' products each year. UL's worldwide family of companies and network of service providers includes 62 laboratory, testing and certification facilities serving customers in 99 countries.   www.ul.com

For a complete listing of all NFPA 1999-2008 UL certified gloves – CLICK HERE

SEI – Safety Equipment Institute

The Safety Equipment Institute (SEI) is a private, non-profit organization that administers a non-governmental, third-party certification program and tests and certifies a broad range of safety and protective products used occupationally and recreationally. SEI certification programs are voluntary and available to any manufacturer of safety and protective equipment seeking to have product models certified by SEI.  

Manufacturers and consumers are assured that products bearing the SEI label have been manufactured to meet the level of quality and performance of the most current comprehensive standards existing for the product.

SEI is accredited by the American National Standards Institute (ANSI) and the Standards Council of Canada (SCC) in accordance with ISO Guide 65, General Requirements for Bodies Operating Product Certification Systems.

SEI has an alliance with INSPEC International, Ltd., a notified body located in the UK. Together, we offer a variety of testing services, CE Marking, and ISO Registration.  www.seinet.org

For a complete listing of all SEI 1999-2008 UL certified gloves –
http://www.seinet.org/search/search.php