|
Device |
condom |
Product Code | HIS |
Regulation Number |
884.5300
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ALATECH HEALTHCARE, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANSELL HEALTHCARE PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANSELL HEATHCARE PRODUCTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHURCH & DWIGHT CO., INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHURCH & DWIGHT CO., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
CHURCH & DWIGHT CO.,INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHURCH & DWIGHT VIRGINIA CO., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CUPID LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBAL MAILER PARTNERS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBAL PROTECTION CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GUANGZHOU DAMING UNITED RUBBER PRODUCTS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANKOOK LATEX GONGUP CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOLLENDER SUSTAINABLE BRANDS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOLATEX (THAILAND) LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KAREX INDUSTRIES SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
KAREX INDUSTRIES SDN BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LELO INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
M3 GLOBAL ENTERPRISES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAPA GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAYER LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICAL-LATEX (DUA) SDN. BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NULATEX SDN. BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
O-RING PRODUCTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OKAMOTO U.S.A., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PROFILATEX, S.A. DE C.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RB HEALTH (US) LLC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SHANGHAI PERSONAGE HYGIENE PRODUCTS CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHEILA PICKERING PH.D. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURETEX LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU COLOUR-WAY NEW MATERIAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THAI NIPPON RUBBER INDUSTRY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THAI NIPPON RUBBER INDUSTRY PUBLIC COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
THAI NIPPON RUBBER INDUSTRY PUBLIC COMPANY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THEYFIT |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TITAN CONDOMS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TTK HEALTHCARE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
TTK PROTECTIVE DEVICES LIMITED (FORMERLY TTK-LIG L |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHEJIANG XIANGBAN LATEX PRODUCTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|