Cleared Traditional

PATIENT EXAMINATION GLOVE (VINYL) (K892565) - FDA 510(k) Clearance

Class I General Hospital device.

K892565 · Kao Ying Industrial Co., Ltd. · General Hospital
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Aug 1989
Decision
118d
Days
Class 1
Risk

K892565 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVE (VINYL). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Kao Ying Industrial Co., Ltd. (Hsien, Taiwan R.O.C., TW). The FDA issued a Cleared decision on August 9, 1989 after a review of 118 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 Kao Ying Industrial Co., Ltd. devices

Submission Details

510(k) Number K892565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1989
Decision Date August 09, 1989
Days to Decision 118 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
11d faster than avg
Panel avg: 129d · This submission: 118d
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 K892565.
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