Cleared Traditional

K894023 - PATIENT EXAMINATION GLOVES (VINYL)

K894023 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVES (VINYL), manufactured by Baxter Healthcare Corp. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

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.

FDA 510(k) Submission Details - K894023

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.

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 K894023.
PATIENT EXAMINATION GLOVES (VINYL)
K892191 · Hsing YI Plastics Processing Co, Ltd. · Sep 1989
NON-STERILE VINYL EXAMINATION GLOVES
K892994 · Sian-Yu Industrial Co., Ltd. · Sep 1989
CHAMP-PAQ VINYL PATIENT EXAM GLOVES
K892079 · Winmed Instruments Mfg. Corp. · Sep 1989
PATIENT EXAMINATION GLOVES (VINYL)
K892164 · King Handy Five Corp. · Aug 1989
VINYL EXAM GLOVES (MFG. TSE FONG)
K892317 · Svenska Medita Ac. · Aug 1989
VINYL EXAM GLOVES (MFG. UNIVERSAL GLOVE CORP.)
K892318 · Svenska Medita Ac. · Aug 1989
K894023 · PATIENT EXAMINATION GLOVES (VINYL)
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