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Laboratory Test Request

510(k) Submission Testing for Water-Based Personal Lubricant

Project Description

MULTIPLE TESTING

We are looking to conduct the following FDA-required tests as part of our 510(k) submission for a personal lubricant product (21 CFR 884.5300):

  1. Biocompatibility Testing (ISO 10993-5, -10, -11) - Cytotoxicity Sensitization Irritation
  2. Condom Compatibility Testing (ASTM D7661) - Evaluation for use with natural rubber latex, polyurethane, and polyisoprene condoms
  3. Osmolality & Viscosity Testing - To confirm compliance with FDA-accepted safety limits

If you have any specific recommendations or additional requirements for FDA compliance, please let us know. We would also appreciate: A quote for these services, the estimated timeline for testing and results delivery, and any sample requirements or additional documentation needed. 

Project Information

Number:25-00510

Industry:Consumer Products

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Other consumer products laboratory services.

Other Consumer Products testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs include :

  • CPSC Product Safety Testing
  • Labeling-Claims Testing
  • Claim Substantiation Testing
  • Clinical Dermatology Evaluation Testing
  • Clinical Evaluations Testing
  • Clinical Ophthalmology Evaluation Testing
  • Comparison Studies Testing
  • Comparative Evaluations Competitive Product Analysis Testing
  • Allergens Testing
  • Toxicity Testing
  • Dermal Irritation Formaldehyde Testing
  • PFAS Testing
  • Microbiology Testing
  • Bacterial Identification Testing
  • Bio Burden Testing
  • Testing

Learn more about consumer products testing and research

Consumer Products,Hygiene, Personal Care, and Toiletries,Personal and Intimate Products,Personal Care Products

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