Cleared Traditional

K012339 - ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW

K012339 is an FDA 510(k) clearance for ENVIORN-NP POWDER FREE SYNTHETIC VINYL ..., manufactured by Shanghai Antares Industries, Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K012339 · Shanghai Antares Industries, Inc. · General Hospital
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Oct 2001
Decision
84d
Days
Class 1
Risk

K012339 is an FDA 510(k) clearance for the ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai Antares Industries, Inc. (Songjiang County, Shanghai, CN). The FDA issued a Cleared decision on October 16, 2001 after a review of 84 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 - K012339

510(k) Number K012339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2001
Decision Date October 16, 2001
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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 K012339.
POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE
K021353 · Glormed Intl., Inc. · Jun 2002
VINYL EXAMINATION GLOVES STERILE POWEDERED
K020044 · Primus Gloves Private , Ltd. · Feb 2002
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K013753 · Canopus Medical Supply Co., Ltd. · Dec 2001
ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
K012499 · Shanghai Antares Industries, Inc. · Oct 2001
DISPOSABLE POWDERED VINYL EXAMINATION GLOVES
K012710 · Shijiazhuang Brilliance Plastic Co., Ltd. · Oct 2001
DISPOSABLE POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K012711 · Shijiazhuang Brilliance Plastic Co., Ltd. · Sep 2001
K012339 · ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW
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