Cleared Traditional

K023343 - ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED

K023343 is an FDA 510(k) clearance for ENVIRON-NP DISPOSABLE SYNTHETIC VINYL E..., 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 21-day FDA review.

K023343 · Shanghai Palomar Mountain Industries, Inc. · General Hospital
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Oct 2002
Decision
21d
Days
Class 1
Risk

K023343 is an FDA 510(k) clearance for the ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED. 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 October 28, 2002 after a review of 21 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 - K023343

510(k) Number K023343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2002
Decision Date October 28, 2002
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
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 K023343.
BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES
K022091 · Tangshan Zhonghong Pulin Group Co., Ltd. · Dec 2002
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K024026 · Shanghai PM Plastics Enterise Co., Ltd. · Dec 2002
ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED
K023560 · Shanghai Palomar Mountain Industries, Inc. · Dec 2002
POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
K022604 · Sun Flower Gloves Co., Ltd. · Oct 2002
MULTIPLE PRIVATE LABELS VINYL EXAMINATION GLOVES, POWDER-FREE
K023235 · Shandong Jiazhan Plastic Products Co., Ltd. · Oct 2002
BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES, SUN FLOWER GLOVES CO., LTD
K022336 · Tangshan Zhonghong Pulin Group Co., Ltd. · Oct 2002
K023343 · ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED
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