510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K010211Substantially Equivalent

Sterile Nitrile Powder-Free Examination Gloves

Medtronic, Inc., Mcgraw Park IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K010211 is the FDA 510(k) clearance record for STERILE NITRILE POWDER-FREE EXAMINATION GLOVES, a class I device, cleared for Allegiance Healthcare Corp. on under FDA product code LZC (Medical Glove, Specialty). FDA's definition for product code LZC reads: "A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition...". FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K010211.

Clearance record

Decision date
Received
(23 days to decision)
Product code
LZC Medical Glove, Specialty
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Allegiance Healthcare Corp. 1500 Waukegan Rd.- K, Mcgraw Park IL
510(k) summary
Summary
Third party review
No

Clearances, product code LZC

Trailing 12 months
1 clearance under product code LZC in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LZC, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260