Cleared Traditional

K031072 - DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E

K031072 is an FDA 510(k) clearance for DISPOSABLE POWDER FREE VINYL EXAM GLOVE..., manufactured by Shanghai Palomar Mountain Industries, Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K031072 · Shanghai Palomar Mountain Industries, Inc. · General Hospital
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May 2003
Decision
32d
Days
Class 1
Risk

K031072 is an FDA 510(k) clearance for the DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai Palomar Mountain Industries, Inc. (Rowland Heights, US). The FDA issued a Cleared decision on May 6, 2003 after a review of 32 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.

View all Shanghai Palomar Mountain Industries, Inc. devices

FDA 510(k) Submission Details - K031072

510(k) Number K031072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2003
Decision Date May 06, 2003
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
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 206
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K031072.
POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR
K032084 · Shen Wei (Usa), Inc. · Oct 2003
SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE
K031750 · Kimberly-Clark Corp. · Oct 2003
VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR
K031913 · Arista Latindo Industrial Ltd. P.T · Jul 2003
VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E
K023753 · Arista Latindo Industrial Ltd. P.T · Mar 2003
VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E
K023754 · Arista Latindo Industrial Ltd. P.T · Mar 2003
STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
K012282 · Cypress Medical Products, Ltd. · Aug 2001