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510(k) K171172

Skyn Original Polyisoprene Lubricated Male Condom - Flavored by Ansell Healthcare Products, LLC — Product Code MOL

K171172 is an FDA 510(k) premarket notification submitted by Ansell Healthcare Products, LLC for the device "Skyn Original Polyisoprene Lubricated Male Condom - Flavored". The FDA issued a decision of Substantially Equivalent on August 2, 2017. The device falls under product code MOL (Condom, Synthetic), a Class II device regulated under 21 CFR 884.5300. Ansell Healthcare Products, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2017
Date Received
April 21, 2017
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Ansell Healthcare Products, LLC

  • K230079 — Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Derm (August 23, 2023)
  • K213289 — Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs (May 26, 2023)
  • K212148 — Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use (March 10, 2022)
  • K210401 — Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Ch (June 13, 2021)
  • K200671 — Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green (June 19, 2020)
  • K190018 — Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemo (May 23, 2019)
  • K182948 — Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs (March 22, 2019)
  • K171375 — Gammex PI Breach Detect Powder Free Surgical Glove (February 6, 2018)
  • K171737 — Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves (December 29, 2017)
  • K163107 — Lifestyles Zero Lubricated Latex Male Condom (January 23, 2017)

Other clearances for product code MOL

  • K252158 — Sagami Original 002 Polyurethane Male Condom (March 30, 2026)
  • K243967 — ONE Nitrile Condom (April 8, 2025)
  • K241617 — Durex Polyisoprene Condom (February 28, 2025)
  • K240379 — TROJAN SIS Synthetic Latex Condom with Silicone Lubricant (October 8, 2024)
  • K240896 — ONE Nitrile Condom (August 23, 2024)
  • K232470 — Polyisoprene Extra Large Condom (May 9, 2024)
  • K231908 — 45 Micron Polyisoprene Condom (October 27, 2023)
  • K203541 — Okamoto 002 Lubricated Polyurethane Male Condom (February 25, 2022)
  • K182438 — Synthetic Polyisoprene Lubricated Male Condom - 5 senses (December 6, 2018)
  • K171639 — Trojan Supra Lubricated Polyurethane Male Condom (August 1, 2017)

FDA data resources