Atlas FDA

Durex Polyisoprene Condom

FDA 510(k) clearance K241617 · decided 2025-02-28

Clearance details

K-number
K241617
Device name
Durex Polyisoprene Condom
Applicant
Rb Health (Us), LLC
Decision
Substantially Equivalent
Date received
2024-06-05
Decision date
2025-02-28
Days to decision
268 days
Clearance type
Traditional
Product code
MOL
Device class
2
Regulation number
884.5300
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Parsippany, NJ, US
Third-party review
No
Expedited review
No

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Okamoto 002 Lubricated Polyurethane Male Condom (K203541)Okamoto USA, Inc.2022-02-25
Synthetic Polyisoprene Lubricated Male Condom - 5 senses (K182438)Sxwell USA, LLC2018-12-06
Skyn Original Polyisoprene Lubricated Male Condom - Flavored (K171172)Ansell Healthcare Products, LLC2017-08-02
Trojan Supra Lubricated Polyurethane Male Condom (K171639)Church & Dwight Co., Inc.2017-08-01
Skyn Original Polyisoprene Lubricated Male Condom (K160399)Ansell Healthcare Products, LLC2016-07-25
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM (K100767)Church & Dwight Co., Inc.2011-04-05

Recalls involving this device

No recalls on record reference this clearance.