Cleared Traditional

K101358 - POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

K101358 is an FDA 510(k) clearance for POWDER-FREE VINYL PATIENT EXAMINATION G..., manufactured by Hebei Handform 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 102-day FDA review.

K101358 · Hebei Handform Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
102d
Days
Class 1
Risk

K101358 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 Hebei Handform Plastic Products Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on August 24, 2010 after a review of 102 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 - K101358

510(k) Number K101358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2010
Decision Date August 24, 2010
Days to Decision 102 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
27d faster than avg
Panel avg: 129d · This submission: 102d
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 K101358.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K102431 · Tangshan Fuqiang Glove Co., Ltd. · Oct 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100421 · Tangshan Yonkshun Glove, Co., Ltd. · Sep 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102098 · Hong DI Plastic Products Co., Ltd. · Sep 2010
POWDER - FREE PATIENT EXAMINATION GLOVES
K101565 · Zibio Yingjie Medical Products Co., Ltd. · Aug 2010
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE
K100977 · Jiangsu Sunshine Plastic Products, Co., Ltd. · Aug 2010
POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE
K100978 · Jiangsu Sunshine Plastic Products, Co., Ltd. · Aug 2010
K101358 · POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Hebei Handform Plasti…