Cleared Traditional

VINYL GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD) (K903847) - FDA 510(k) Clearance

Class I General Hospital device.

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

Submission Details

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.

Device Classification

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 84
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
TRU-TOUCH VINYL, NON-STERILE
K891719 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
TRU-TOUCH VINYL, STERILE
K892327 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989