510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040916Substantially Equivalent

Vitalcare Powder Free Synthetic Vinyl Examination Glove

Vitalcare Group, Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040916 is the FDA 510(k) clearance record for VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE, a class I device, cleared for Vitalcare Group, 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 8 510(k) clearances for Vitalcare Group, Inc., from to . As of , FDA records show no recalls naming K040916.

Clearance record

Decision date
Received
(391 days to decision)
Product code
LYZ Vinyl Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Vitalcare Group, Inc. 8935 NW 27th St., Miami FL
510(k) summary
Summary PDF
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