Cleared Traditional

K102097 - POWDER FREE VINYL PATIENT EXAMINATION GLOVES

K102097 is an FDA 510(k) clearance for POWDER FREE VINYL PATIENT EXAMINATION G..., manufactured by Shijiazhuang Great Vision Plastic Products Co., LT. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K102097 · Shijiazhuang Great Vision Plastic Products Co., LT · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
113d
Days
Class 1
Risk

K102097 is an FDA 510(k) clearance for the POWDER FREE VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhuang Great Vision Plastic Products Co., LT (Chino, US). The FDA issued a Cleared decision on November 17, 2010 after a review of 113 days - within the typical 510(k) review window.

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 - K102097

510(k) Number K102097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2010
Decision Date November 17, 2010
Days to Decision 113 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
16d faster than avg
Panel avg: 129d · This submission: 113d
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 K102097.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K103198 · Youngshengplastic Co., Ltd. · Dec 2010
POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLORED)
K102976 · Heze Juxinyuan Food Co., Ltd. · Dec 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K102444 · Zibo Yingbo Medical Products, Inc. · Nov 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102171 · Wuxi Bingfa Gainlite Gloves Cp., Ltd. · Nov 2010
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
K102097 · POWDER FREE VINYL PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Shijiazhuang Great Vi…