510(k) clearances

Durex Polyisoprene Condom

Rb Health (Us), LLC · Obstetrics/Gynecology

K241617Substantially EquivalentTraditionalMOL
Open FDA's page for this record
Third party flag
N
City
Parsippany
Advisory committee description
Obstetrics/Gynecology
Address 1
399 Interpace Pkwy.
Statement or summary
Statement
Product code
MOL
Zip code
07054
Applicant
Rb Health (Us), LLC
Decision date
2025-02-28
Decision code
SESE
Country code
US
Device name
Durex Polyisoprene Condom
Advisory committee
OB
Contact
Matthew Pleus
K number
K241617
State
NJ
Date received
2024-06-05
Review advisory committee
OB
Postal code
07054
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Condom, Synthetic
Medical specialty description
Obstetrics/Gynecology
Regulation number
884.5300
Device class
2
Registration number
2531449, 3003491851, 2086832, 1000136042, 3013770781, 1122329, 2938651, 9680135, 3006122980, 1222115, 3003071219, 8040641, 3003896222, 3003592318, 2280705, 3011015568, 3007829481, 9613932
FEI number
1000535235, 3003491851, 3003979157, 1000136042, 3010687142, 3002808272, 3013770781, 1122329, 2938651, 3001687671, 3006122980, 3002921123, 3003071219, 1222115, 3003592318, 2280705, 3011015568, 3007829481
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.