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510(k) K001212

TROJAN EXTRA LARGE LATEX CONDOM by Armkel, LLC — Product Code HIS

K001212 is an FDA 510(k) premarket notification submitted by Armkel, LLC for the device "TROJAN EXTRA LARGE LATEX CONDOM". The FDA issued a decision of Substantially Equivalent on May 9, 2000. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Armkel, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2000
Date Received
April 14, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

Other clearances by Armkel, LLC

  • K040866 — FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST (October 19, 2004)
  • K030258 — FIRST RESPONSE PREGNANCY TEST (February 25, 2003)
  • K023405 — TROJAN MINT TINGLE BRAND LATEX CONDOMS (December 16, 2002)
  • K013433 — TROJAN PASSION BERRY GEL (March 5, 2002)
  • K013614 — TROJAN CRYSTAL CLEAR LIQUID (February 1, 2002)
  • K000748 — TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT (April 6, 2000)
  • K992232 — FIRST RESPONSE 1-STEP PREGNANCY (December 21, 1999)
  • K973310 — TBD* ONE-STEP OVULATION PREDICTOR TEST (October 27, 1997)
  • K973352 — BRAND NAME *1-STEP PREGNANCY (October 27, 1997)
  • K963318 — LEGIONELLA IGG/IGM ELISA TEST SYSTEM (March 3, 1997)

Other clearances for product code HIS

  • K252622 — Male Latex Condom HA (May 4, 2026)
  • K252521 — LifeStyles® HydraFeel Natural Rubber Latex Condom (November 18, 2025)
  • K250034 — Natural rubber latex male condom (July 11, 2025)
  • K243421 — Lelo Hex Lubricated Natural Rubber Latex Condom (March 7, 2025)
  • K243640 — Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed E (February 21, 2025)
  • K243584 — 0.04 ZERO ZERO FOUR Male Latex Condom (February 18, 2025)
  • K232279 — LifeStyles NRL Textured Condom (October 5, 2023)
  • K230049 — SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE (September 7, 2023)
  • K222611 — Male Latex Condoms (November 28, 2022)
  • K220489 — Durex Patronus CloseFit, Durex Patronus Regular (November 7, 2022)

FDA data resources