Cleared Traditional

K962026 - PREPOWDER VINYL PATIENT EXAMINATION GLOVES

K962026 is an FDA 510(k) clearance for PREPOWDER VINYL PATIENT EXAMINATION GLOVES, manufactured by Hong Huang Tang Industrial Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K962026 · Hong Huang Tang Industrial Co., Ltd. · General Hospital
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Sep 1996
Decision
110d
Days
Class 1
Risk

K962026 is an FDA 510(k) clearance for the PREPOWDER VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Hong Huang Tang Industrial Co., Ltd. (Billerica, US). The FDA issued a Cleared decision on September 10, 1996 after a review of 110 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 Hong Huang Tang Industrial Co., Ltd. devices

FDA 510(k) Submission Details - K962026

510(k) Number K962026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1996
Decision Date September 10, 1996
Days to Decision 110 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 129d · This submission: 110d
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 141
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K962026.
VINYL PATIENT EXAMINATION GLOVES
K964629 · Arista Medi Prima · Feb 1997
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K964964 · Sunmax Enterprise Shanghai Co. , Ltd. · Feb 1997
POWDER FREE VINYL EXAMINATION GLOVE
K964545 · Shanghai Poseidon Plastic Products Co., Ltd. · Dec 1996
MEDLINE PRE-POWDERED NON-STERILE/STERILE VINYL EXAMINATION GLOVES
K962069 · Medline Industries, Inc. · Aug 1996
ARISTA VINYL EXAMINATION GLOVES
K954153 · Arista Latindo Industrial Ltd. P.T · Jan 1996
TRIFLEX STERILE SYNTHETIC EXAMINATION GLOVES
K952786 · Baxter Healthcare Corp · Jul 1995