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Condom Testing

Personal Lubricants and Condoms Testing               Contact John Passero, 1-800-220-3675 ext. 3604                  

The testing is conducted according to established ASTM methods and FDA guidance. The personal lubricant compatibility consists of testing against latex and/or non-latex condoms to evaluate the compatibility with the condom material, according to method ASTM D7661-10. The compatibility is determined by the percentage change of air burst parameters (burst volume and burst pressure) and tensile parameters (break force and elongation) between the treated and untreated condoms.

The results of the testing following this standard usually affect lubricant labeling with respect to condom use. This testing required for the FDA 510(k) pre-market notification submission of personal lubricants. The condoms testing suite at EMSL Analytical, inc. consists of evaluation of the air burst and tensile parameters. These tests are used for evaluation of both latex and synthetic condoms and are performed in compliance with ASTM D3492-08 (for natural rubber latex condoms) and ASTM D6324-11 (for synthetic condoms).
 
Example of reporting for Personal Lubricants Testing per FDA requirements:


Condom Type

Break Force (%)

Elongation (%) Change

Burst Pressure (%) Change

Burst Volume (%) Change

Trojan Latex, (Non-Lubricated) Lot #TT3202WZ1422

0.2

3.6

-6.4

-7.2

Lifestyles Latex, (Non-Lubricated)
Lot #1310111522

4.6

5.3

-5.6

1.8

Durex Latex (Non-Lubricated) Lot#0010034446

2.3

4.8

-5.0

-6.1

Lifestyles Skyn Polyisoprene (Lubricated) Lot #1203343216

1.7

1.3

-6.6

1.8

TrojanSupra Polyurethane (Lubricated) Lot #CZ3127E5

-3.3

-4.2

-3.9

-1.3



Full list of services provided for Condom Testing ( click for details )
Laboratories providing Condom Testing ( click for details )
Ann Arbor, MI - NVLAP Lab Code 101048-4Atlanta, GA - NVLAP Lab Code 101048-1Baton Rouge, LA - NVLAP Lab Code 200375-0Beltsville, MD - NVLAP Lab Code 200293-0Boston, MA - NVLAP Lab Code 101147-0Buffalo, NY - NVLAP Lab Code 200056-0Calgary, Alberta - NVLAP Lab Code 500100-0Carle Place, NY - NVLAP Lab Code 101048-10Charlotte, NC - NVLAP Lab Code 200841-0Chicago, IL - NVLAP Lab Code 200399-0Corporate - Cinnaminson, NJ - NVLAP Lab Code 101048-0Dallas, TX - NVLAP Lab Code 600111-0Denver, CO - NVLAP Lab Code 200828-0EMSL Canada - Montreal -- Quebec - NVLAP Lab Code 201052-0EMSL Canada -- Toronto - NVLAP Lab Code 200877-0EMSL Canada Inc. -- Ottawa - NVLAP Lab Code 201040-0Fort Lauderdale - NVLAP Lab Code 500085-0Houston, TX - NVLAP Lab Code 102106-0Huntington Beach, CA - NVLAP Lab Code 101384-0Indianapolis, IN - NVLAP Lab Code 200188-0Kernersville, NC - NVLAP Lab Code 102104-0Las Vegas, NV - NVLAP Lab Code 600140-0Miami, FL - NVLAP Lab Code 200204-0Minneapolis IH Lab (EAST) - NVLAP Lab Code 101234-0Minneapolis, MN (WEST) - NVLAP Lab Code 200019-0New York, NY - NVLAP Lab Code 101048-9Orlando, FL - NVLAP Lab Code 101151-0Pasadena, CA - NVLAP Lab Code 200232-0Phoenix, AZ - NVLAP Lab Code 200811-0Piscataway, NJ - NVLAP Lab Code 101048-2Plymouth Meeting, PA - NVLAP Lab Code 200699-0Raleigh, NC - NVLAP Lab Code 200671-0Rochester, NY - NVLAP Lab Code 600183-0S. Portland, ME - NVLAP Lab Code 500094-0Salem, NH - NVLAP Lab Code 201051-0San Diego, CA - NVLAP Lab Code 200855-0San Leandro, CA - NVLAP Lab Code 101048-3Seattle, WA - NVLAP Lab Code 200613-0St. Louis, MO - NVLAP Lab Code 200742-0Vancouver, BC - NVLAP Lab Code 201068-0Wallingford, CT - NVLAP Lab Code 200700-0