Cleared Traditional

K102655 - POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA (YELLOW, WHITE, BLUE)

K102655 is an FDA 510(k) clearance for POWDER FREE VINYL SYNTHETIC EXAMINATION..., 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 44-day FDA review.

K102655 · 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
Oct 2010
Decision
44d
Days
Class 1
Risk

K102655 is an FDA 510(k) clearance for the POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA (YELLOW, WHITE,.... 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 October 29, 2010 after a review of 44 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 - K102655

510(k) Number K102655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2010
Decision Date October 29, 2010
Days to Decision 44 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 129d · This submission: 44d
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 K102655.
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
K102558 · Tangshan Hengda Plastic Products Co., Ltd. · Nov 2010
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE
K102337 · Curon Scientific Co., Ltd. · Nov 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102093 · Shijiazhuang Great Vision Plastic Products Co., LT · Nov 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K102559 · Tangshan Hengda Plastic Products Co., Ltd. · Oct 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K102569 · Tangshan Kangyuan Glove Co., Ltd. · Oct 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K102570 · Tangshan Kangjie Glove Co., Ltd. · Oct 2010
K102655 · POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA (YELLOW, WHITE, BLUE)
Download PDF FDA Summary Ever Light Plastic Pr…