510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K122696Substantially Equivalent

Powder-Free Nitrile Examination Gloves (Cool Blue)

Medtronic, Inc., Waukegan IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122696 is the FDA 510(k) clearance record for POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE), a class I device, cleared for Cardinal Health, Inc. on under FDA product code LZA (Polymer Patient Examination Glove). FDA's definition for product code LZA reads: "A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to...". FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K122696.

Clearance record

Decision date
Received
(149 days to decision)
Product code
LZA Polymer Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Cardinal Health, Inc. 1430 Waukegan Rd., Waukegan IL
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code LZA

Trailing 12 months
15 clearances under product code LZA in the twelve months to November 2026, June 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code LZA, trailing twelve months
MonthClearances
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20265
July 20262
August 20261
September 20264
October 20261
November 20260