Cleared Traditional

K981360 - VINYL PATIENT EXAMINATION GLOVE, POWDERED

K981360 is an FDA 510(k) clearance for VINYL PATIENT EXAMINATION GLOVE, manufactured by Glormed Intl., Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K981360 · Glormed Intl., Inc. · General Hospital
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Oct 1998
Decision
184d
Days
Class 1
Risk

K981360 is an FDA 510(k) clearance for the VINYL PATIENT EXAMINATION GLOVE, POWDERED. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Glormed Intl., Inc. (Sparks, US). The FDA issued a Cleared decision on October 15, 1998 after a review of 184 days - an extended review 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: 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 Glormed Intl., Inc. devices

FDA 510(k) Submission Details - K981360

510(k) Number K981360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1998
Decision Date October 15, 1998
Days to Decision 184 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
55d slower than avg
Panel avg: 129d · This submission: 184d
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 205
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K981360.
VINYL EXAM GLOVES, POWDER FREE
K983494 · Glormed Intl., Inc. · Nov 1998
POWDER-FREE NON STERILE VINYL EXAMINATION GLOVES
K983612 · Shanghai Jiatai Plastic Products Co., Ltd. · Nov 1998
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K983207 · Shijiazhuang Great Eagle Plastic Products Co., Ltd. · Oct 1998
DISPOSABLE VINYL EXAM GLOVES, POWDERED
K982687 · Shanghai Antares Industries, Inc. · Oct 1998
SYNTHETIC EXAMINATION GLOVE, POWDERED
K981876 · Hsing YI Plastics Processing Co, Ltd. · Sep 1998
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
K982704 · Shanghai Antares Industries, Inc. · Sep 1998