Cleared Traditional

K043478 - POWDERED YELLOW SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE

K043478 is an FDA 510(k) clearance for POWDERED YELLOW SYNTHETIC VINYL EXAMINA..., manufactured by Shijaizhuang Brilliant Ocean Plastic Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K043478 · Shijaizhuang Brilliant Ocean Plastic Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
83d
Days
Class 1
Risk

K043478 is an FDA 510(k) clearance for the POWDERED YELLOW SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-L.... Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijaizhuang Brilliant Ocean Plastic Co., Ltd. (Chino, US). The FDA issued a Cleared decision on March 9, 2005 after a review of 83 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.

View all Shijaizhuang Brilliant Ocean Plastic Co., Ltd. devices

FDA 510(k) Submission Details - K043478

510(k) Number K043478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2004
Decision Date March 09, 2005
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 277
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K043478.
VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR
K061562 · Grand Work Plastic Products Co., Ltd. · Jul 2006
ESTEEM STRETCHY VINYL GLOVE WITH COATING
K052568 · Cardinalhealth · Nov 2005
POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING
K051683 · Shen Wei (Usa), Inc. · Aug 2005
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES
K042830 · Grand Work Plastic Products Co., Ltd. · Nov 2004
SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K040682 · Grand Work Plastic Products Co., Ltd. · Jul 2004
SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWERED
K041225 · Grand Work Plastic Products Co., Ltd. · Jul 2004