Cleared Traditional

K971316 - POLY (VINYL) EXAM GLOVE, POWDERED

K971316 is an FDA 510(k) clearance for POLY (VINYL) EXAM GLOVE, manufactured by Copioumed Intl., Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K971316 · Copioumed Intl., Inc. · General Hospital
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Aug 1997
Decision
140d
Days
Class 1
Risk

K971316 is an FDA 510(k) clearance for the POLY (VINYL) EXAM GLOVE, POWDERED. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Copioumed Intl., Inc. (Green Valley, US). The FDA issued a Cleared decision on August 27, 1997 after a review of 140 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 Copioumed Intl., Inc. devices

FDA 510(k) Submission Details - K971316

510(k) Number K971316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1997
Decision Date August 27, 1997
Days to Decision 140 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
11d slower than avg
Panel avg: 129d · This submission: 140d
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 138
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K971316.
VINYL PATIENT EXAMINATION GLOVES POWDERED
K973902 · Everrise Glove Products Co., Ltd. · Nov 1997
VINYL PATIENT EXAMINATION GLOVES POWDER-FREE
K973998 · Everrise Glove Products Co., Ltd. · Nov 1997
POLY (VINYL) EXAM GLOVE, POWDER-FREE
K972624 · Copioumed Intl., Inc. · Nov 1997
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