Cleared Traditional

K893334 - PREPOWDERED VINYL EXAM GLOVES

K893334 is an FDA 510(k) clearance for PREPOWDERED VINYL EXAM GLOVES, manufactured by Dynarex Corp.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K893334 · Dynarex Corp. · General Hospital
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Aug 1989
Decision
117d
Days
Class 1
Risk

K893334 is an FDA 510(k) clearance for the PREPOWDERED VINYL EXAM GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Dynarex Corp. (Brewster, US). The FDA issued a Cleared decision on August 15, 1989 after a review of 117 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 Dynarex Corp. devices

FDA 510(k) Submission Details - K893334

510(k) Number K893334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1989
Decision Date August 15, 1989
Days to Decision 117 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 129d · This submission: 117d
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 120
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K893334.
FEATHERWEIGHT VINYL, NON-STERILE EXAM GLOVES
K892328 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
PATIENT EXAMINATION GLOVES (VINYL)
K892754 · Baxter Healthcare Corp · Sep 1989
PATIENT EXAMINATION GLOVES (VINYL)
K894023 · Baxter Healthcare Corp · Aug 1989
TRU-TOUCH VINYL EXAM GLOVES (BELGIUM)
K891948 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1989
TRU-TOUCH VINYL EXAM GLOVES (CANADA)
K891952 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1989
PATIENT EXAMINATION GLOVES (VINYL)
K891717 · Ulti-Med Intl., Inc. · May 1989