510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896835Substantially Equivalent

Alcohol Prep and Povidone-Iodine Prep

Norpak Mfg., Inc., Ajax, Ontario L1z 1e2, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896835 is the FDA 510(k) clearance record for ALCOHOL PREP AND POVIDONE-IODINE PREP, cleared for Norpak Mfg., Inc. on under FDA product code LKB (Pad, Alcohol, Device Disinfectant). FDA records list 2 510(k) clearances for Norpak Mfg., Inc., from to . As of , FDA records show no recalls naming K896835.

Clearance record

Decision date
Received
(37 days to decision)
Product code
LKB Pad, Alcohol, Device Disinfectant
Device class
Unclassified
Review panel
Unknown
Applicant
Norpak Mfg., Inc. 85 Chambers Dr., #8, Ajax, Ontario L1z 1e2, CA
Third party review
No

Clearances, product code LKB

Trailing 12 months

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

FDA records show no clearances under product code LKB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LKB, 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