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 Contraceptives
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
Male Latex Condom - Requirements and Test Methods
WHO 2004
Latex Condoms – Accelerated Aging 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 – AirBurst Properties
Natural Rubber Latex Male Condoms - Requirements and Test Methods
ISO 4074-1
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
