Cleared Traditional

K092302 - POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR

K092302 is an FDA 510(k) clearance for POWDER FREE VINYL SYNTHETIC EXAMINATION..., 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 280-day FDA review.

K092302 · 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
May 2010
Decision
280d
Days
Class 1
Risk

K092302 is an FDA 510(k) clearance for the POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR. 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 May 5, 2010 after a review of 280 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K092302

510(k) Number K092302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2009
Decision Date May 05, 2010
Days to Decision 280 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
151d slower than avg
Panel avg: 129d · This submission: 280d
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 K092302.
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100735 · Rayu Plastic Products Limited · May 2010
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K100294 · Zibo Yinghao Medical Products Co., Ltd. · May 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100697 · Shijiazhuang Universal Channel Plastic Co., Ltd. · May 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K100486 · Zibo Yinghao Medical Products Co., Ltd. · May 2010
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE, YELLOW/WHITE
K093263 · Qingdao Lang Hui Import & Export Co., Ltd. · Apr 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100733 · Rayen Safety Products Limited · Apr 2010
K092302 · POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR
Download PDF FDA Summary Bettercare Plastic Pr…