510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K896098Substantially Equivalent

Guardian & Janitex Condom/prophylactic

Allied Rubber Industries Sdn. Bhd., 400000 Shah Alam.Malaysia, MY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896098 is the FDA 510(k) clearance record for GUARDIAN & JANITEX CONDOM/PROPHYLACTIC, a class II device, cleared for Allied Rubber Industries Sdn. Bhd. on under FDA product code HIS (Condom). FDA records list 2 510(k) clearances for Allied Rubber Industries Sdn. Bhd., from to . As of , FDA records show no recalls naming K896098.

Clearance record

Decision date
Received
(425 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Allied Rubber Industries Sdn. Bhd. 2009, Kawasan Miel, 400000 Shah Alam.Malaysia, MY
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