Cleared Traditional

K903847 - VINYL GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD)

K903847 is an FDA 510(k) clearance for VINYL GLOVE-POWEDERFREE (OBERON GLOVES ..., manufactured by Zest Mark Industrial Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K903847 · Zest Mark Industrial Co., Ltd. · General Hospital
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Jan 1991
Decision
163d
Days
Class 1
Risk

K903847 is an FDA 510(k) clearance for the VINYL GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Zest Mark Industrial Co., Ltd. (Taiwan, Roc, TW). The FDA issued a Cleared decision on January 31, 1991 after a review of 163 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.

View all Zest Mark Industrial Co., Ltd. devices

FDA 510(k) Submission Details - K903847

510(k) Number K903847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1990
Decision Date January 31, 1991
Days to Decision 163 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 129d · This submission: 163d
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 606
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K903847.
DERMACARE SYNTHETIC MEDICAL GLOVE
K914763 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
SENSICARE SYNTHETIC MEDICAL GLOVES
K915478 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1992
B-D(R) HYPOALLERGENIIC NON-STERILE PAT EXAM GLOVES
K913902 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1991
TRU-TOUCH POWDER FREE
K905503 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1991
ANSELL CONFORM GREEN EXAMINATION GLOVES
K897081 · Ansell, Inc. · Mar 1990
TRU-TOUCH VINYL, NON-STERILE
K891719 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989