Cleared Traditional

K002814 - DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR

K002814 is an FDA 510(k) clearance for DISPOSBABLE POWDERED VINYL SYNTHETIC EX..., manufactured by Shanghai PM Plastics Enterise Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K002814 · Shanghai PM Plastics Enterise Co., Ltd. · General Hospital
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Oct 2000
Decision
39d
Days
Class 1
Risk

K002814 is an FDA 510(k) clearance for the DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai PM Plastics Enterise Co., Ltd. (Shongjiang County, Shanghai, CN). The FDA issued a Cleared decision on October 20, 2000 after a review of 39 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 - K002814

510(k) Number K002814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2000
Decision Date October 20, 2000
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
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 K002814.
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR
K003321 · Shanghai Antares Industries, Inc. · Nov 2000
MULTIPLE-VINYL EXAM GLOVE, POWDERED
K003133 · Excellence Ent. Co., Ltd. · Nov 2000
MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW
K003091 · Medline Industries, Inc. · Oct 2000
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K002870 · Shanghai PT Plastics Enterprise Company, Ltd. · Oct 2000
VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR
K002745 · Arista Latindo Industrial Ltd. P.T · Oct 2000
VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR
K002746 · Arista Latindo Industrial Ltd. P.T · Oct 2000
K002814 · DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
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