510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K884692Substantially Equivalent

The Safegard Personal Protection Kit

The Safegard Protection Corp., Wailuku HI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884692 is the FDA 510(k) clearance record for THE SAFEGARD PERSONAL PROTECTION KIT, a class II device, cleared for The Safegard Protection Corp. on under FDA product code HIS (Condom). FDA records list one 510(k) clearance for The Safegard Protection Corp. As of , FDA records show no recalls naming K884692.

Clearance record

Decision date
Received
(307 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
The Safegard Protection Corp. P.O. Box 2474, Wailuku HI
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