Cleared Traditional

K060778 - SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWDER FREE

K060778 is an FDA 510(k) clearance for SYNTHETIC VINYL PATIENT EXAMINATION GLO..., manufactured by Ever Light Plastic 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 37-day FDA review.

K060778 · Ever Light Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
37d
Days
Class 1
Risk

K060778 is an FDA 510(k) clearance for the SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWDER FREE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Ever Light Plastic Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on April 28, 2006 after a review of 37 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 - K060778

510(k) Number K060778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2006
Decision Date April 28, 2006
Days to Decision 37 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
92d faster than avg
Panel avg: 129d · This submission: 37d
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 741
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K060778.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K060884 · Wei Fang Jiuzhou Gloves Co., Ltd. · May 2006
POWDERED VINYL PATIENT EXAMINATION GLOVES
K060886 · Wei Fang Jiuzhou Gloves Co., Ltd. · May 2006
SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWERED
K060784 · Ever Light Plastic Products Co., Ltd. · May 2006
PRE-POWDERED STERILE VINYL GLOVE, CLEAR
K053521 · Shijiazhuang Hongxiang Plastics Products Co; , Ltd. · Mar 2006
POWDER FREE STERILE VINYL GLOVE (CLEAR AND YELLOW)
K053523 · Shijiazhuang Hongxiang Plastics Products Co; , Ltd. · Feb 2006
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K052729 · Shijiazhuang Brilliant Ocean Plastic Co., Ltd. · Jan 2006
K060778 · SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWDER FREE
Download PDF FDA Summary Ever Light Plastic Pr…