510(k) clearances

Sagami Original 002 Polyurethane Male Condom

Mayer Laboratories · Obstetrics/Gynecology

K252158Substantially EquivalentTraditionalMOL
Open FDA's page for this record
Third party flag
N
City
Berkeley
Advisory committee description
Obstetrics/Gynecology
Address 1
1400 Shattuck Ave. Suite 9
Statement or summary
Summary
Product code
MOL
Zip code
94709
Applicant
Mayer Laboratories
Decision date
2026-03-30
Decision code
SESE
Country code
US
Device name
Sagami Original 002 Polyurethane Male Condom
Advisory committee
OB
Contact
David Mayer
K number
K252158
State
CA
Date received
2025-07-09
Review advisory committee
OB
Postal code
94709
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
8040641, 3013770781, 3003071219, 3003592318, 1122329, 2531449, 2938651, 2280705, 2086832, 3003896222, 9680135, 3006122980, 3011015568, 3007829481, 1222115, 3003491851, 9613932, 1000136042
FEI number
1000535235, 3013770781, 3003071219, 3002921123, 3003592318, 3010687142, 1122329, 2938651, 2280705, 3003979157, 3001687671, 3006122980, 3011015568, 3007829481, 1222115, 3003491851, 1000136042, 3002808272
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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.