510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K050360Substantially Equivalent

Tulip Condom

Shanghai Latex Factory, Shanghai, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050360 is the FDA 510(k) clearance record for TULIP CONDOM, a class II device, cleared for Shanghai Latex Factory on under FDA product code HIS (Condom). FDA records list 3 510(k) clearances for Shanghai Latex Factory, from to . As of , FDA records show no recalls naming K050360.

Clearance record

Decision date
Received
(15 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Shanghai Latex Factory 1700 Huang Xing Rd., Shanghai, CN
510(k) summary
Summary PDF
Third party review
Yes

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