510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K080833Substantially Equivalent

Love Guard Male Latex Condom

Tianjin Human-Care Latex Corporation, West Windsor NJ / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080833 is the FDA 510(k) clearance record for LOVE GUARD MALE LATEX CONDOM, a class II device, cleared for Tianjin Human-Care Latex Corporation on under FDA product code HIS (Condom). FDA records list one 510(k) clearance for Tianjin Human-Care Latex Corporation. As of , FDA records show no recalls naming K080833.

Clearance record

Decision date
Received
(135 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Tianjin Human-Care Latex Corporation 56 Danville Dr., West Windsor NJ
510(k) summary
Summary PDF
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