Cleared Traditional

K040108 - OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN

K040108 is an FDA 510(k) clearance for OPUE-E DISPOSABLE POWDER FREE VINYL SYN..., manufactured by Est International Corporation. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K040108 · Est International Corporation · General Hospital
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Aug 2004
Decision
210d
Days
Class 1
Risk

K040108 is an FDA 510(k) clearance for the OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLE.... Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Est International Corporation (Rancho Cucamonga, US). The FDA issued a Cleared decision on August 17, 2004 after a review of 210 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K040108

510(k) Number K040108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2004
Decision Date August 17, 2004
Days to Decision 210 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 129d · This submission: 210d
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 798
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K040108.
SYNTHETIC (BLUE) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE
K042247 · Shijiazhuang Hongxiang Plastics Products Co; , Ltd. · Sep 2004
PRE-POWDERED VINYL EXAM GLOVES
K041379 · Shijiazhuang Wally Plastics Co., Ltd. · Aug 2004
POWDER-FREE BLUE VINYL EXAM GLOVES
K041945 · Glormed Intl., Inc. · Aug 2004
VINYL EXAMINATION GLOVE, POWDER-FREE, NON-STERILE
K042028 · Zibo Borui Plastic & Rubber Products Co., Ltd. · Aug 2004
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
K040108 · OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN
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