Cleared Traditional

K040916 - VITALCARE POWDER FREE SYNTHETIC VINYL E...

K040916 is an FDA 510(k) clearance for VITALCARE POWDER FREE SYNTHETIC VINYL E..., manufactured by Vitalcare Group, Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 391-day FDA review.

K040916 · Vitalcare Group, Inc. · General Hospital
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May 2005
Decision
391d
Days
Class 1
Risk

K040916 is an FDA 510(k) clearance for the VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Vitalcare Group, Inc. (Miami, US). The FDA issued a Cleared decision on May 4, 2005 after a review of 391 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Vitalcare Group, Inc. devices

FDA 510(k) Submission Details - K040916

510(k) Number K040916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2004
Decision Date May 04, 2005
Days to Decision 391 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
262d slower than avg
Panel avg: 129d · This submission: 391d
Pathway characteristics
Predicate-based equivalence.

LYZ Device Classification - Class 1, General Controls

Product Code LYZ Vinyl Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition 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 Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LYZ Vinyl Patient Examination Glove

All 93
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K040916.
Glide-On Vinyl Examination Gloves
K151754 · Medline Industries, Inc. · Mar 2016
ESTEEM STRETCHY VINYL GLOVE WITH COATING
K052568 · Cardinalhealth · Nov 2005
POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING
K051683 · Shen Wei (Usa), Inc. · Aug 2005
POWDERED VINYL EXAMINATION GLOVES
K033692 · Shen Wei (Usa), Inc. · Jan 2004
POWDER-FREE VINYL EXAMINATION GLOVES
K033693 · Shen Wei (Usa), Inc. · Jan 2004
DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR
K033539 · Shen Wei (Usa), Inc. · Jan 2004