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510(k) K902305

TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM. by Armkel, LLC — Product Code HIS

K902305 is an FDA 510(k) premarket notification submitted by Armkel, LLC for the device "TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.". The FDA issued a decision of Substantially Equivalent on March 29, 1991. 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
March 29, 1991
Date Received
May 22, 1990
Clearance Type
Traditional
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)
  • K001212 — TROJAN EXTRA LARGE LATEX CONDOM (May 9, 2000)
  • K000748 — TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT (April 6, 2000)
  • K992232 — FIRST RESPONSE 1-STEP PREGNANCY (December 21, 1999)
  • K973352 — BRAND NAME *1-STEP PREGNANCY (October 27, 1997)
  • K973310 — TBD* ONE-STEP OVULATION PREDICTOR TEST (October 27, 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