510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K990597Substantially Equivalent

Summer's Eve Lubricating Jelly

C.B. Fleet Co., Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990597 is the FDA 510(k) clearance record for SUMMER'S EVE LUBRICATING JELLY, a class II device, cleared for C.B. Fleet Co., Inc. on under FDA product code HIS (Condom). FDA records list 2 510(k) clearances for C.B. Fleet Co., Inc., from to . As of , FDA records show no recalls naming K990597.

Clearance record

Decision date
Received
(145 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
C.B. Fleet Co., Inc. 1050 Connecticut Ave., NW, Washington DC
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