|
Device |
lubricant, personal |
Definition |
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. |
Product Code | NUC |
Regulation Number |
884.5300
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ANSELL HEALTHCARE PRODUCTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ANSELL HEALTHCARE PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BATH CONCEPT COSMETICS (DONGGUAN) CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIO-TECH LUBRICANTS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOFILM INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOFILM INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
BIOFILM, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BIOTECH LUBRICANTS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOYA BIOTECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARRASHIELD LABS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CC WELLNESS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
CEWAL, INC. DBA PREMIERE ENTERPRISES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHURCH & DWIGHT CO., INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CHURCH & DWIGHT CO., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
COCONU, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COMBE INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CURVES LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DESERT HARVEST, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DR. AUGUST WOLFF GMBH & CO. KG ARZEIMITTEL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DR. AUGUST WOLFF GMBH & CO. KG ARZNEIMITTEL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DREAMBRANDS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMPOWERED PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FAIRHAVEN HEALTH, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FARMA-DERMA S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FEMMEPHARMA CONSUMER HEALTHCARE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FIDIA FARMACEUTICI S.P.A |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FIDIA FARMACEUTICI SPA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FOSHAN PINGCHUANG MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GOOD CLEAN LOVE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GOOD CLEAN LOVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
GRAFENBERG LABS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUY & O'NEILL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ICM PHARMA PTE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMQUEST BIOSCIENCES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOVEMED BIO-TECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
JIANGXI WULINXIANG BIOLOGICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JOHNSON & JOHNSON CONSUMER & PERSONAL PRODUCTS WOR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JOHNSON & JOHNSON HEALTHCARE PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KAREX INDUSTRIES SDN. BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KIMBERLY-CLARK CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LACLEDE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LFBEAUTY (THAILAND) LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIL DRUG STORE PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LOVE ALCHEMY LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MANO AND MANO PROPRIETARY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAYER LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MD LABS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NANTONG HEALTH & BEYOND HYGIENIC PRODUCTS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NATUREPLEX, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NECESSAIRE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEO COSMETIQUE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NON-FRICTION PRODUCTS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ONE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PACKAGE SOLUTIONS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PEPTONIC MEDICAL AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PERRIGO NEW YORK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHARMAPAC LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PJUR GROUP LUXEMBOURG SA |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
PJUR GROUP,LUXEMBOURG S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PLAYGROUND FOR ALL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
POLICHEM S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
R&R MEDICAL CORPORATION LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RB HEALTH (US) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RB HEALTH (US) LLC |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
RECKITT BENCKISER |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RECKITT BENCKISER LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
RECKITT BENCKISER, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
REOXCYN, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SASMAR INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SELECT LABS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEVEN OAKS RANCH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN HUANQIU XUEBAO TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIMPLY SOLUTIONS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOLEVY CO. LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SURETEX LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SXWELL USA LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THAI NIPPON RUBBER INDUSTRY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THAI NIPPON RUBBER INDUSTRY PUBLIC COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THAI NIPPON RUBBER INDUSTRY PUBLIC COMPANY LIMITED. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THE BLOOMI INC.. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
THE KAMA SUTRA COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOASTER LABS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TOPCO SALES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TORO MANAGEMENT LLC DBA SYLK |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRIGG LABORATORIES D/B/A WET INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRIGG LABORATORIES DBA WET INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRIGG LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
TRIGG LABORATORIES, INC. D/B/A WET INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TROPHIKOS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TYROS BIOPHARMA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UBERLUBE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNIDERM FARMACEUTICI SRL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
UNITED CONSORTIUM |
|
SUBSTANTIALLY EQUIVALENT
|
13
|
UNITED CONSORTIUM INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VALENCIA NATURALS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VALENCIA NATURALS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VIRAMAL LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VJUVENATE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WESTRIDGE LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WETTRUST KOREA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WISCONSIN PHARMACAL CO., LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WOO ESSENTIALS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WSM INVESTMENT LLC, DBA TOPCO SALES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WTFN-DBA CLASSIC EROTICA/HOLIDAY PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XR LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|