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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lubricant, personal, gamete, fertilization, and embryo compatible
Regulation Description Condom.
Definition A personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This device may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms. This device is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. This device may also be used during fertility interventions to facilitate entry of diagnostic and therapeutic devices.
Product CodePEB
Regulation Number 884.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOFILM, INC.
  SUBSTANTIALLY EQUIVALENT 1

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