Cleared Traditional

K970144 - VINYL EXAM GLOVE POWERED

K970144 is an FDA 510(k) clearance for VINYL EXAM GLOVE POWERED, manufactured by Hiyi Export Co.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K970144 · Hiyi Export Co. · General Hospital
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Apr 1997
Decision
97d
Days
Class 1
Risk

K970144 is an FDA 510(k) clearance for the VINYL EXAM GLOVE POWERED. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Hiyi Export Co. (Green Valley, US). The FDA issued a Cleared decision on April 22, 1997 after a review of 97 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 Hiyi Export Co. devices

FDA 510(k) Submission Details - K970144

510(k) Number K970144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1997
Decision Date April 22, 1997
Days to Decision 97 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 129d · This submission: 97d
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 139
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K970144.
LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES
K972104 · Shinemound Enterprise, Inc. · Aug 1997
VINYL PATIENT EXAMINATION GLOVE, POWDER-FREE
K971415 · Shanghai Foremost Plastic Industrial Co., Ltd. · May 1997
VINYL PATIENT EXAMINATION GLOVE, POWDERED
K971423 · Shanghai Foremost Plastic Industrial Co., Ltd. · May 1997
JIAWANG POWDER-FREE VINYL EXAMINATION GLOVES
K970111 · Shanghai Jiawang Industrial Co. , Ltd. · Mar 1997
JIAWANG PRE-POWDERED VINYL EXAMINATION GLOVES
K964800 · Shanghai Jiawang Industrial Co. , Ltd. · Feb 1997
VINYL PATIENT EXAMINATION GLOVES
K964629 · Arista Medi Prima · Feb 1997