510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K012653Substantially Equivalent

Male Latex Condom

Qingdao Shuang die Latex Production Co.,Ltd, Durham NC / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K012653 is the FDA 510(k) clearance record for MALE LATEX CONDOM, a class II device, cleared for Qingdao Shuang Die Latex Production Co.,Ltd on under FDA product code HIS (Condom). FDA records list one 510(k) clearance for Qingdao Shuang Die Latex Production Co.,Ltd. As of , FDA records show no recalls naming K012653.

Clearance record

Decision date
Received
(39 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Qingdao Shuang Die Latex Production Co.,Ltd 1219 Little Creek Rd., Durham NC
510(k) summary
Statement
Third party review
No

Clearances, product code HIS

Trailing 12 months
3 clearances under product code HIS in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIS, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260