510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994118Substantially Equivalent

Osmanthus, Kongfu, and Gobon, Natural Rubber Latex Condoms

Guilin Latex Factory, San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994118 is the FDA 510(k) clearance record for OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS, a class II device, cleared for Guilin Latex Factory on under FDA product code HIS (Condom). FDA records list one 510(k) clearance for Guilin Latex Factory. As of , FDA records show one recall naming K994118.

Clearance record

Decision date
Received
(252 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Guilin Latex Factory 93 Morningside Dr., San Francisco CA
510(k) summary
Summary
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