Cleared Traditional

PATIENT EXAMINATION GLOVES (VINYL) (K894023) - FDA 510(k) Clearance

Class I General Hospital device.

K894023 · Baxter Healthcare Corp · General Hospital
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Aug 1989
Decision
86d
Days
Class 1
Risk

K894023 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVES (VINYL). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on August 31, 1989 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K894023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1989
Decision Date August 31, 1989
Days to Decision 86 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
43d faster than avg
Panel avg: 129d · This submission: 86d
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 83
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K894023.
TRU-TOUCH VINYL, STERILE
K892327 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
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
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