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510(k) K202667

Personal Lubricant Jelly by Nantong Health & Beyond Hygienic Products, Inc. — Product Code NUC

K202667 is an FDA 510(k) premarket notification submitted by Nantong Health & Beyond Hygienic Products, Inc. for the device "Personal Lubricant Jelly". The FDA issued a decision of Substantially Equivalent on May 18, 2021. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2021
Date Received
Sep 14, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lubricant, Personal
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type
510(k)

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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FDA data resources