Home / 510(k) Clearances / K222068

510(k) K222068

Durex Penck III Regular by Rb Health (Us), LLC — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2022
Date Received
July 14, 2022
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 Rb Health (Us), LLC

  • K241617 — Durex Polyisoprene Condom (February 28, 2025)
  • K230781 — Belle Sensilube (June 20, 2023)
  • K213892 — Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine (March 7, 2023)
  • K220489 — Durex Patronus CloseFit, Durex Patronus Regular (November 7, 2022)
  • K211152 — Durex Condom with Benzocaine (May 11, 2022)
  • K213400 — Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz (March 1, 2022)
  • K213647 — Durex Patronus Wide (February 17, 2022)
  • K211088 — Grosz Play Feel (July 9, 2021)
  • K200672 — Durex Penck Standard, Durex Penck XL (November 6, 2020)
  • K201186 — KY Grosz Jelly (July 30, 2020)

Other clearances for product code HIS

  • 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)
  • K221906 — TROJAN Fire & Ice lubricated male natural rubber latex condom (September 28, 2022)