510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040071Substantially Equivalent

Ennoble Disposable Powder Free Vinyl Synthetic Exam Gloves with Vitamin Complex, Nopal and Lanolin

Elite International, Inc., Rowland Heights CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K040071 is the FDA 510(k) clearance record for ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN, a class I device, cleared for Elite International, Inc. on under FDA product code LYZ (Vinyl Patient Examination Glove). FDA's definition for product code LYZ reads: "A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) 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 provide a barrier against...". FDA records list 4 510(k) clearances for Elite International, Inc., from to . As of , FDA records show no recalls naming K040071.

Clearance record

Decision date
Received
(141 days to decision)
Product code
LYZ Vinyl Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Elite International, Inc. 18709 Greenbay Dr., Rowland Heights CA
510(k) summary
Statement
Third party review
No

Clearances, product code LYZ

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