‘ONE TOUCH’ LATEX CONDOM WITH NONOXYNOL-9


the company

Device Classification Name

condom with nonoxynol-9

510(k) Number K001978
Device Name ‘ONE TOUCH’ LATEX CONDOM WITH NONOXYNOL-9
Original Applicant
THAI NIPPON RUBBER INDUSTRY CO., LTD.
1219 little creek rd.
durham, 
NC 
27713

Original Contact eli j carter
Regulation Number 884.5310
Classification Product Code
LTZ  
Date Received 06/29/2000
Decision Date 08/08/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

Type Abbreviated
Reviewed by Third Party No

Combination Product

No