Cleared Traditional

K050455 - SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES

K050455 is an FDA 510(k) clearance for SYNTHETIC POWEDERED VINYL EXAMINATION G..., manufactured by Zibo Blue Intco Plastic & Rubber Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K050455 · Zibo Blue Intco Plastic & Rubber Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
35d
Days
Class 1
Risk

K050455 is an FDA 510(k) clearance for the SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Zibo Blue Intco Plastic & Rubber Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on March 29, 2005 after a review of 35 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 - K050455

510(k) Number K050455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2005
Decision Date March 29, 2005
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
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 K050455.
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K051153 · Hebei Manful Import & Export Co., Ltd. · May 2005
VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE
K040916 · Vitalcare Group, Inc. · May 2005
SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES
K050450 · Zibo Blue Intco Plastic & Rubber Products Co., Ltd. · Apr 2005
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
K050455 · SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES
Download PDF Zibo Blue Intco Plast…