Cleared Traditional

K030148 - DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR

K030148 is an FDA 510(k) clearance for DISPOSABLE POWDER FREE VINYL SYNTHETIC ..., 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 35-day FDA review.

K030148 · Shanghai Palomar Mountain Industries, Inc. · General Hospital
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Feb 2003
Decision
35d
Days
Class 1
Risk

K030148 is an FDA 510(k) clearance for the DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai Palomar Mountain Industries, Inc. (Songjiang Shanghai, CN). The FDA issued a Cleared decision on February 19, 2003 after a review of 35 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 - K030148

510(k) Number K030148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2003
Decision Date February 19, 2003
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
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 749
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K030148.
SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES
K030484 · Emerald Medical, Inc. · Mar 2003
POWDER FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDE
K024338 · General Gloves Corp. · Mar 2003
TOP GLOVE VINYL EXAMINATION GLOVE
K024216 · Top Glove (Zhangjiagang) Co. , Ltd. · Feb 2003
POWDERED VINYL EXAMINATION GLOVES
K024016 · Top Glove (Zhangjiagang) Co. , Ltd. · Feb 2003
DISPOSBLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K024081 · Safehealth Medical Supply Corp. · Jan 2003
NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES
K024174 · General Gloves Corp. · Jan 2003
K030148 · DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
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