Laboratory Test Request

Personal Lubricant FDA Predicate Medical Device Submission Testing

Project Description

MULTIPLE TESTING
FDA GMP Laboratory needed for the following testing for a Personal Lubricant: Predicate device

1. Cytotoxicity per ISO 10993-5: 2009
2. Sensitization and Irritation testing using the human repeat insult patch testing, an
alternative test method to ISO 10993-10:2010
3. Acute systemic toxicity testing per ISO 10993-11:2017.
ASTM D7661-
3. Standard Test Method for Determining Compatibility of Personal Lubricants with
Natural Rubber Latex Condoms

Project Information

Number:21-01595

Industry:Medical Devices

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Personal and Intimate Products,Personal Care Products,Contraception Products,Hygiene, Personal Care, and  Toiletries,Medical Devices,Pharmaceutical - Over the Counter (OTC),Pharmaceuticals ,

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