510(k) clearances

Polyisoprene Extra Large Condom

Suretex Limited · Obstetrics/Gynecology

K232470Substantially EquivalentAbbreviatedMOL
Open FDA's page for this record
Third party flag
N
City
Suratthani
Advisory committee description
Obstetrics/Gynecology
Address 1
31/1 Moo 4, Suratthani-Thakuapha Rd.
Address 2
Tambon Khao Kwai, Amphur Phunphin
Statement or summary
Summary
Product code
MOL
Zip code
84130
Applicant
Suretex Limited
Decision date
2024-05-09
Decision code
SESE
Country code
TH
Device name
Polyisoprene Extra Large Condom
Advisory committee
OB
Contact
Alison Arnot
K number
K232470
Date received
2023-08-16
Review advisory committee
OB
Postal code
84130
Decision description
Substantially Equivalent
Clearance type
Abbreviated
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.