Laboratory Test Request

Menstrual Sponge Preclinical Testing (Microbiology, Physical, Chemistry)

Project Description

Medical Device Laboratory needed for the following testing of a new menstrual sponge (soft tampon) made of a polyurethane foam:Absorbency range via Syngyna testing as specified in 21 CFR 801.430(f)(2)Chemical residue testing and Preclinical microbiology testing to demonstrate that the product does not enhance the growth of Stapylococcus aureus increase production of TSST-1alter the growth of normal vaginal microfloraFor the latter (preclinical microbiology) testing, if you have previously used different methods for testing S. aureus in tampons

Project Information

Number:23-00277

Industry:Personal Care Products

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