Cleared Traditional

K040071 - ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN

K040071 is an FDA 510(k) clearance for ENNOBLE DISPOSABLE POWDER FREE VINYL SY..., manufactured by Elite International, Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K040071 · Elite International, Inc. · General Hospital
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Jun 2004
Decision
141d
Days
Class 1
Risk

K040071 is an FDA 510(k) clearance for the ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPL.... Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Elite International, Inc. (Rowland Heights, US). The FDA issued a Cleared decision on June 3, 2004 after a review of 141 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Elite International, Inc. devices

FDA 510(k) Submission Details - K040071

510(k) Number K040071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2004
Decision Date June 03, 2004
Days to Decision 141 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 129d · This submission: 141d
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 298
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K040071.
SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K040682 · Grand Work Plastic Products Co., Ltd. · Jul 2004
SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWERED
K041225 · Grand Work Plastic Products Co., Ltd. · Jul 2004
VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
K041745 · Arista Latindo Industrial Ltd. P.T · Jul 2004
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K040681 · Grand Work Plastic Products Co., Ltd. · Jun 2004
GRAND WORK PLASTICS PRODUCTS CO., LTD., SYNTHETIC VINYL PATIENT EXAMINATION GLOVES - POWDERED
K041188 · Grand Work Plastic Products Co., Ltd. · Jun 2004
SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE
K040702 · Grand Work Plastic Products Co., Ltd. · Apr 2004