Glove & Condom

ARDL offers many glove and condom testing services and can help you with FDA detention and compliance. Tests for gloves and condoms include air burst, chemical and drug permeation, dimensional evaluation, flex testing, freedom from holes, humidity and heat aging, hydration testing, latex protein testing, lubricant evaluation, package integrity, polymer/coating identification, powder content and resistance to creams and lotions.

FDA Detention & Compliance Services

Importers of latex/rubber medical devices occasionally experience US FDA Detention at Port of Entry. When this occurs ARDL can help with:

      • On-Site Sampling by ARDL Personnel
      • Training of Third Party Personnel to Sample
      • FedEx of Test Data to FDA Compliance Officer
      • Telephone & Fax Contact with FDA at Port of Entry to Resolve Problems
      • Familiarity with Special Requirements of Specific FDA Branch Offices

 

More information on extractables/leachables, chemotherapy drug testing and analytical testing of Medical Gloves and Condoms is available in Chemical Testing.

Available Methods

Air Burst for Rubber Contraceptives (Male Condoms)

Standard Specification for Rubber Contraceptives (Male Condoms)

ASTM D 3492

Condom Lubricant Compatibility Testing

Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms

ASTM D 7661

Detection of Holes in Medical Gloves

Standard Test Method for Detection of Holes in Medical Gloves

ASTM D 5151

Determination of Resistance to Water Penetration

Determination of Resistance to Water Penetration This is the reference test specified by the European Standard for the assessment of glove quality. Gloves must pass this test in order to prove that they are an effective barrier against liquids and micro-organisms. A statistical sample taken from a batch of gloves is subject to checks for pinholes and leaks by either inflation with air or by filling with water. Performance levels are assessed according to the acceptable quality levels (AQL) of the gloves. Gloves must meet at least level 2 of EN374-2 to be considered micro-organism resistant.

EN 374-2

Dimensional Analysis - Latex Condoms

Natural Rubber Latex Male Condoms - Requirements and Test Methods

ISO 4074

Dimensional Analysis - Medical Glove

Medical Gloves for Single Use - Requirements and Testing for Physical Properties

BS EN 455-2

Dimensional Analysis - Nitrile Examination Gloves for Medical Application

Standard Specification for Nitrile Examination Gloves for Medical Application

ASTM D 6319

Dimensional Analysis - Polychloroprene Examination Gloves for Medical Application

Standard Specification for Polychloroprene Examination Gloves for Medical Application

ASTM D 6977

Dimensional Analysis - PVC Gloves for Medical Applications

Standard Specification for Poly(vinyl chloride) Gloves for Medical Application

ASTM D 5250

Dimensional Analysis - Rubber Contraceptves

Standard Specification for Rubber Contraceptives (Male Condoms)

ASTM D 3492

Dimensional Analysis - Rubber Examination Gloves

Standard Specification for Rubber Examination Gloves

ASTM D 3578

Dimensional Analysis - Surgical Gloves

Standard Specification for Rubber Surgical Gloves

ASTM D 3577

Electrical Testing on Gloves, Sect 18.6 - Ozone Resistance

Standard Specification for Rubber Insulating Gloves

ASTM D 120

Latex Condoms - Accelerated Aging AirBurst Properties

Natural Rubber Latex Male Condoms - Requirements and Test Methods

ISO 4074-1

Latex Condoms - Accelerated Aging AirBurst Properties

Male Latex Condom - Requirements and Test Methods

WHO 2004

Latex Condoms - AirBurst Properties

Natural Rubber Latex Male Condoms - Requirements and Test Methods

ISO 4074-1

Latex Condoms - AirBurst Properties

Male Latex Condom - Requirements and Test Methods

WHO 2004

Latex Condoms - Custom Testing

Natural Rubber Latex Male Condoms - Requirements and Test Methods

ISO 4074-1

Latex Condoms - Custom Testing

Male Latex Condom - Requirements and Test Methods

WHO 2004

Latex Condoms - Dimensional Analysis

Natural Rubber Latex Male Condoms - Requirements and Test Methods

ISO 4074-1

Latex Condoms - Dimensional Analysis

Male Latex Condom - Requirements and Test Methods

WHO 2004

Latex Condoms - Labeling

Natural Rubber Latex Male Condoms - Requirements and Test Methods

ISO 4074-1

Latex Condoms - Labeling

Male Latex Condom - Requirements and Test Methods

WHO 2004

Latex Condoms - Water Leakage

Natural Rubber Latex Male Condoms - Requirements and Test Methods

ISO 4074-1

Latex Condoms - Water Leakage

Male Latex Condom - Requirements and Test Methods

WHO 2004

Lubricant Testing - Gloves - Tensile Strength

Lubricant Testing on Gloves - Tensile

ARDL 2140

Lubricant Testing - Gloves - Water Leakage

Lubricant Testing on Gloves - Water Leakage

ARDL 2140

Male Condom Testing - Polyurethane Condom

Standard Test Methods for Male Condoms Made from Polyurethane

ASTM D 6324

Medical Gloves - Freedom from Holes

Medical Gloves for Single Use - Part 1 Requirements and Testing for Freedom From Holes

BS EN 455-1

Natural Rubber Latex Male Condom Testing

Natural Rubber Latex Male Condoms Requirements and Test Methods

BS 3704 (Withdrawn) Replaced by BS EN 600

Rubber Examination Gloves

Standard Specification for Rubber Examination Gloves

ASTM D 3578

Water Burst for Rubber Contraceptives (Male Condoms)

Standard Specification for Rubber Contraceptives (Male Condoms)

ASTM D 3492