Cleared Traditional

K110247 - POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR

K110247 is an FDA 510(k) clearance for POWDER FREE NUTRILE PATIENT EXAMINATION..., manufactured by Jiangsu Dongling Plastic & Rubber Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K110247 · Jiangsu Dongling Plastic & Rubber Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
133d
Days
Class 1
Risk

K110247 is an FDA 510(k) clearance for the POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Jiangsu Dongling Plastic & Rubber Co., Ltd. (Rd. Hai Di Beijing, CN). The FDA issued a Cleared decision on June 10, 2011 after a review of 133 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.

View all Jiangsu Dongling Plastic & Rubber Co., Ltd. devices

FDA 510(k) Submission Details - K110247

510(k) Number K110247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2011
Decision Date June 10, 2011
Days to Decision 133 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
4d slower than avg
Panel avg: 129d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 766
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K110247.
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE
K111772 · Kossan Latex Industries(M)Sdn Bhd · Oct 2011
NITRILE POWDER FREE EXAMINATION GLOVES
K110758 · Hartalega Sdn Bhd · Aug 2011
POWDER FREE NITRILE EXAMINATION GLOVES
K111328 · Gx Corporation Sdn Bhd · Jul 2011
BLUE POWDERFREE NITRILE EXAMINATION GLOVE
K102623 · Pt. Medisafe Technologies · Jun 2011
SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL
K103770 · Syntex Healthcare Products Co., Ltd. · Apr 2011
NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K110921 · Cardinal Health, Inc. · Apr 2011