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510(k) K013433

TROJAN PASSION BERRY GEL by Armkel, LLC — Product Code NUC

K013433 is an FDA 510(k) premarket notification submitted by Armkel, LLC for the device "TROJAN PASSION BERRY GEL". The FDA issued a decision of Substantially Equivalent on March 5, 2002. The device falls under product code NUC (Lubricant, Personal), 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 5, 2002
Date Received
October 16, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lubricant, Personal
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.

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)
  • 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)
  • 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 NUC

  • K261177 — PINKSLIP Water-Based Personal Lubricant and Moisturizer (July 9, 2026)
  • K261909 — Plum Vagiceuticals™ Vaginal Moisturizing Suppositories (July 6, 2026)
  • K254011 — Flow Water-Based Personal Lubricant (June 22, 2026)
  • K261292 — PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) (June 11, 2026)
  • K252914 — Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) (June 9, 2026)
  • K260068 — pjur NATURE Touch, 100 ml (May 21, 2026)
  • K254101 — Julva Velvé Water-Based Personal Lubricant (April 16, 2026)
  • K260007 — Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Supposito (April 1, 2026)
  • K253983 — Water-based lubricant (March 6, 2026)
  • K251011 — Chiavaye Personal Moisturizer (December 19, 2025)

FDA data resources