Wet Essential95 Personal Lubricant

FDA 510(k) K220534 · Trigg Laboratories, Inc.

Substantially Equivalent

510(k) numberK220534

Submission

Device name
Wet Essential95 Personal Lubricant
Applicant
Trigg Laboratories, Inc.
Las Vegas, NV, US
Received
February 24, 2022
Decision date
July 7, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NUC – Lubricant, Personal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5300
Specialty
Obstetrics/Gynecology

This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.

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More from Hudi Pharma Srl

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K221829Wet Flavored Personal LubricantsNUC · Traditional 09/23/2022SE
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Questions and answers

When was Wet Essential95 Personal Lubricant cleared by the FDA?

Wet Essential95 Personal Lubricant (K220534) received a 510(k) decision of Substantially Equivalent on July 7, 2022, 133 days after the submission was received.

What is the product code of K220534?

The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.