Cleared Traditional

K031142 - DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR

K031142 is an FDA 510(k) clearance for DISPOSABLE POWDERED VINYL SYNTHETIC EXA..., 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 195-day FDA review.

K031142 · Shanghai Palomar Mountain Industries, Inc. · General Hospital
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Mar 2004
Decision
195d
Days
Class 1
Risk

K031142 is an FDA 510(k) clearance for the DISPOSABLE POWDERED 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 March 17, 2004 after a review of 195 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 Shanghai Palomar Mountain Industries, Inc. devices

FDA 510(k) Submission Details - K031142

510(k) Number K031142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2003
Decision Date March 17, 2004
Days to Decision 195 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
66d slower than avg
Panel avg: 129d · This submission: 195d
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 K031142.
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K040681 · Grand Work Plastic Products Co., Ltd. · Jun 2004
GRAND WORK PLASTICS PRODUCTS CO., LTD., SYNTHETIC VINYL PATIENT EXAMINATION GLOVES - POWDERED
K041188 · Grand Work Plastic Products Co., Ltd. · Jun 2004
SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE
K040702 · Grand Work Plastic Products Co., Ltd. · Apr 2004
POWDERED VINYL EXAMINATION GLOVES
K033692 · Shen Wei (Usa), Inc. · Jan 2004
POWDER-FREE VINYL EXAMINATION GLOVES
K033693 · Shen Wei (Usa), Inc. · Jan 2004
DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR
K033539 · Shen Wei (Usa), Inc. · Jan 2004