510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991047Substantially Equivalent

Hardcover Condoms Male Latex Condoms, (with Spermicide)

Hardcover Products, Inc., Concord, Ontario, CA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K991047 is the FDA 510(k) clearance record for HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE), a class II device, cleared for Hardcover Products, Inc. on under FDA product code LTZ (Condom With Nonoxynol-9). FDA records list 2 510(k) clearances for Hardcover Products, Inc., from to . As of , FDA records show no recalls naming K991047.

Clearance record

Decision date
Received
(80 days to decision)
Product code
LTZ Condom With Nonoxynol-9
Regulation
21 CFR 884.5310
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Hardcover Products, Inc. 55 Administration Rd., Unit 12, Concord, Ontario, CA
510(k) summary
Statement
Third party review
No

Clearances, product code LTZ

Trailing 12 months

FDA records hold no clearances under product code LTZ in the trailing twelve months.

FDA records show no clearances under product code LTZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LTZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260