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510(k) K001978

'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 by Thai Nippon Rubber Industry Co., Ltd. — Product Code LTZ

K001978 is an FDA 510(k) premarket notification submitted by Thai Nippon Rubber Industry Co., Ltd. for the device "'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9". The FDA issued a decision of Substantially Equivalent on August 8, 2000. The device falls under product code LTZ (Condom With Nonoxynol-9), a Class II device regulated under 21 CFR 884.5310. Thai Nippon Rubber Industry Co., Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2000
Date Received
June 29, 2000
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom With Nonoxynol-9
Device Class
Class II
Regulation Number
884.5310
Review Panel
OB
Submission Type

Other clearances by Thai Nippon Rubber Industry Co., Ltd.

  • K142790 — OneTouch Lubricant Gel (July 30, 2015)
  • K081265 — THAI NIPPON MALE LATEX CONDOM (October 16, 2009)
  • K032909 — THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM (December 16, 2003)
  • K011253 — FLAVORED MALE LATEX CONDOM (July 20, 2001)
  • K994095 — LATEX CONDOM (January 18, 2000)

Other clearances for product code LTZ

  • K033163 — CAUTION CONDOMS (April 27, 2004)
  • K012969 — DOUBLE SPRINGERS NONOXNOL 9 CONDOM (June 12, 2002)
  • K010178 — SPERMICIDAL LUBRICATED MALE LATEX CONDOM (April 27, 2001)
  • K003375 — CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX (January 28, 2001)
  • K001377 — SPERMICIDAL LUBRICATED MALE LATEX CONDOM (June 8, 2000)
  • K992438 — INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) (August 2, 1999)
  • K991047 — HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) (June 18, 1999)
  • K990669 — MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9) (May 17, 1999)
  • K981955 — MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS (March 15, 1999)
  • K981621 — ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS (June 19, 1998)

FDA data resources