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Lubricants Testing

Personal Lubricants and Condoms Testing                

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 D7661-18. 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 D3492-16 (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 Lubricants Testing ( click for details )
Personal Lubricants and Condoms Testing
Laboratories providing Lubricants Testing ( click for details )
Atlanta, GA (LAB 07) - NVLAP Lab Code 101048-1Baton Rouge, LA (LAB 25) - NVLAP Lab Code 200375-0Beltsville, MD (LAB 19) - NVLAP Lab Code 200293-0Boston, MA (LAB 13) - NVLAP Lab Code 101147-0Buffalo, NY (LAB 14) - NVLAP Lab Code 200056-0Carle Place, NY (LAB 06) - NVLAP Lab Code 101048-10Charlotte, NC (LAB 41) - NVLAP Lab Code 200841-0Chicago, IL (LAB 26) - NVLAP Lab Code 200399-0Cinnaminson, NJ (LAB List in Description) - NVLAP Lab Code 101048-0Dallas, TX (LAB 11) - NVLAP Lab Code 600111-0Denver, CO (LAB 22) - NVLAP Lab Code 200828-0EMSL Canada - Calgary, AB (LAB 65) - NVLAP Lab Code 500100-0EMSL Canada - Edmonton, AB (LAB 50) - NVLAP Lab Code 600321-0EMSL Canada - Markham, ON (LAB 66) - NVLAP Lab Code 600317-0EMSL Canada - Montreal, QC (LAB 68) - NVLAP Lab Code 201052-0EMSL Canada - Ottawa, ON (LAB 67) - NVLAP Lab Code 201040-0EMSL Canada - Toronto, ON (LAB 55) - NVLAP Lab Code 200877-0EMSL Canada - Vancouver, BC (LAB 69) - NVLAP Lab Code 201068-0Fort Lauderdale, FL (LAB 56) - NVLAP Lab Code 500085-0Houston, TX (LAB 15) - NVLAP Lab Code 102106-0Huntington Beach, CA (LAB 33) - NVLAP Lab Code 101384-0Indianapolis, IN (LAB 16) - NVLAP Lab Code 200188-0Kernersville, NC (LAB 02) - NVLAP Lab Code 102104-0Long Island City, NY (LAB 03) - NVLAP Lab Code 101048-9Meriden, CT (LAB 24) - NVLAP Lab Code 200700-0Miami, FL (LAB 17) - NVLAP Lab Code 200204-0Minneapolis, MN (LAB 35) - NVLAP Lab Code 200019-0Ontario, California (San Bernadino County / Inland Empire) (LAB 71) - NVLAP Lab Code 600239-0Orlando, FL (LAB 34) - NVLAP Lab Code 101151-0Phoenix, AZ (LAB 12) - NVLAP Lab Code 200811-0Piscataway, NJ (LAB 05) - NVLAP Lab Code 101048-2Plymouth Meeting, PA (LAB 18) - NVLAP Lab Code 200699-0Raleigh, NC (LAB 29) - NVLAP Lab Code 200671-0Rochester, NY (LAB 53) - NVLAP Lab Code 600183-0San Diego, CA (LAB 43) - NVLAP Lab Code 200855-0San Leandro, CA (LAB 09) - NVLAP Lab Code 101048-3Santa Clara, CA (LAB 47) - NVLAP Lab Code 600318-0Seattle, WA (LAB 51) - NVLAP Lab Code 200613-0South Pasadena, CA (LAB 32) - NVLAP Lab Code 200232-0South Portland, ME (LAB 62) - NVLAP Lab Code 500094-0St. Louis, MO (LAB 39) - NVLAP Lab Code 200742-0Tampa, FL (LAB 93) - NVLAP Lab Code 600215-0
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