Cleared Traditional

K092301 - POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK)

K092301 is an FDA 510(k) clearance for POWDER FREE VINYL PATIENT EXAMINATION G..., manufactured by Bettercare 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 85-day FDA review.

K092301 · Bettercare 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 2009
Decision
85d
Days
Class 1
Risk

K092301 is an FDA 510(k) clearance for the POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Bettercare Plastic Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on October 22, 2009 after a review of 85 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 - K092301

510(k) Number K092301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2009
Decision Date October 22, 2009
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
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 749
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K092301.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093270 · Tangshan Excellence Glove Co., Ltd. · Nov 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093276 · Tangshan Kangyuan Glove Co., Ltd. · Nov 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K092790 · Zibo Boxiang Plastic & Rubber Co., Ltd. · Nov 2009
VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLOR
K092294 · Bettercare Plastic Products Co., Ltd. · Oct 2009
POWDER FREE EXAMINATION GLOVE
K092296 · Bettercare Plastic Products Co., Ltd. · Oct 2009
PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL
K091471 · Cartagloves S.A. · Oct 2009
K092301 · POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK)
Download PDF FDA Summary Bettercare Plastic Pr…