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510(k) K981955

MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS by Ls Rubber Sdn Bhd — Product Code LTZ

K981955 is an FDA 510(k) premarket notification submitted by Ls Rubber Sdn Bhd for the device "MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS". The FDA issued a decision of Substantially Equivalent on March 15, 1999. The device falls under product code LTZ (Condom With Nonoxynol-9), a Class II device regulated under 21 CFR 884.5310. Ls Rubber Sdn Bhd has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1999
Date Received
June 4, 1998
Clearance Type
Traditional
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 Ls Rubber Sdn Bhd

  • K020633 — NATURAL AND COLORED LATEX CONDOM WITH FLAVORS (May 15, 2002)
  • K980964 — MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS (March 12, 1999)

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)
  • K001978 — 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 (August 8, 2000)
  • 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)
  • K981621 — ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS (June 19, 1998)

FDA data resources