Cleared Traditional

K050154 - POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)

K050154 is an FDA 510(k) clearance for POWDER-FREE VINYL PATIENT EXAMINATION G..., manufactured by Zibo Zhuangyuan Plastic & Rubber Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K050154 · Zibo Zhuangyuan Plastic & Rubber Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
14d
Days
Class 1
Risk

K050154 is an FDA 510(k) clearance for the POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Zibo Zhuangyuan Plastic & Rubber Co., Ltd. (Chaoyang District; Beijing, CN). The FDA issued a Cleared decision on February 7, 2005 after a review of 14 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 - K050154

510(k) Number K050154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2005
Decision Date February 07, 2005
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
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 K050154.
PRE-POWDERED VINYL EXAM GLOVES
K042951 · Zibo Hengchang Plastic & Rubber Products Co., Ltd. · Mar 2005
VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE
K042952 · Zibo Hengchang Plastic & Rubber Products Co., Ltd. · Mar 2005
POWDERED YELLOW SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
K043478 · Shijaizhuang Brilliant Ocean Plastic Co., Ltd. · Mar 2005
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K050155 · Zibo Zhuangyuan Plastic & Rubber Co., Ltd. · Feb 2005
POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
K043499 · Shijaizhuang Brilliant Ocean Plastic Co., Ltd. · Feb 2005
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K043475 · Shijiazhuang Winful Plastic Co., Ltd. · Feb 2005
K050154 · POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
Download PDF FDA Summary Zibo Zhuangyuan Plast…