DUREX SYNTHETIC POLYISOPRENE MALE CONDOM— 510(k) K072169
Substantially EquivalentSsl Americas, Inc.
FDA 510(k) clearance K072169 for DUREX SYNTHETIC POLYISOPRENE MALE CONDOM, Substantially Equivalent on 2008-06-19. Applicant: Ssl Americas, Inc.. Device class: 2.
Clearance details
- Applicant
- Ssl Americas, Inc.
- Product code
- Code MOL
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Norcross, GA, US
Recent devices under product code MOL
view allMore clearances from Ssl Americas, Inc.
view allRecalls naming K072169
K-number listed on FDA's recall record- Z-0993-2019 — Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-95767-00 02340-89456-14 02340-89457-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-89455-00 02340-95767-00 02340-95767-00
- Z-0994-2019 — Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00
- Z-0091-2019 — Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
- Z-3241-2018 — Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072169.
Data sourced from openFDA. This site is unofficial and independent of the FDA.