Cleared Traditional

K171317 - Clear Vinyl Powder-free Patient Examination Gloves

K171317 is an FDA 510(k) clearance for Clear Vinyl Powder-free Patient Examina..., manufactured by Shandong Zhi Hong Medical 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 130-day FDA review.

K171317 · Shandong Zhi Hong Medical Products, Co. , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
130d
Days
Class 1
Risk

K171317 is an FDA 510(k) clearance for the Clear Vinyl Powder-free Patient Examination Gloves. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shandong Zhi Hong Medical Products, Co. , Ltd. (Qingzhou, CN). The FDA issued a Cleared decision on September 11, 2017 after a review of 130 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 - K171317

510(k) Number K171317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2017
Decision Date September 11, 2017
Days to Decision 130 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
1d slower than avg
Panel avg: 129d · This submission: 130d
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 Consultant

Intco Medical Industries, Inc.
Melo Zhang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LYZ Vinyl Patient Examination Glove

All 716
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K171317.
Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color
K173016 · Anhui Kindguard Medical Supplies Technology Co., Ltd. · Nov 2017
STERILE VINYL EXAMINATION GLOVES, Powder Free
K170612 · Primus Gloves Pvt Limited · Oct 2017
Powder-free Clear Vinyl Patient Examination Gloves
K171460 · Shandong Zhiwei Medical Products, Co. , Ltd. · Sep 2017
Powder-Free Clear Vinyl Patient Examination Gloves
K170735 · Zibo Yue Fan Medical Products Co, Ltd. · Jun 2017
Disposable Powder Free Vinyl Exam Glove, Clear/Yellow
K170575 · Ever Global (Vietnam) Enterprise Corp · May 2017
Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)
K163168 · Hebei Hongtai Plastic Products Company Limited · Feb 2017