Cleared Traditional

K031134 - DISPOSABLE POWDERED VINYL EXAM GLOVES

K031134 is an FDA 510(k) clearance for DISPOSABLE POWDERED VINYL EXAM GLOVES, manufactured by Elite International, Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K031134 · Elite International, Inc. · General Hospital
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May 2003
Decision
41d
Days
Class 1
Risk

K031134 is an FDA 510(k) clearance for the DISPOSABLE POWDERED VINYL EXAM GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Elite International, Inc. (Rowland Heights, US). The FDA issued a Cleared decision on May 20, 2003 after a review of 41 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K031134

510(k) Number K031134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2003
Decision Date May 20, 2003
Days to Decision 41 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
88d faster than avg
Panel avg: 129d · This submission: 41d
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 798
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K031134.
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
K031076 · Synmertex Co, Ltd. · May 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
K031120 · Synmertex Co, Ltd. · May 2003
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES
K031171 · Synmertex Co, Ltd. · May 2003
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K031293 · Shijiazhuang Eversharp Plastic Products Co., Ltd. · May 2003
DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E
K031072 · Shanghai Palomar Mountain Industries, Inc. · May 2003
POWDERED VINYL EXAM GLOVES, WHITE
K030997 · Heyuan Hongli Industries, Inc. · May 2003
K031134 · DISPOSABLE POWDERED VINYL EXAM GLOVES
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