Cleared Traditional

K182640 - Powder Free Nitrile Examination Gloves ...

K182640 is the FDA 510(k) clearance for Powder Free Nitrile Examination Gloves ... by Shandong Hengya Packaging Printing Co.,Ltd. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K182640 · Shandong Hengya Packaging Printing Co.,Ltd · General Hospital
Download Printable Device Report (PDF)
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Apr 2019
Decision
200d
Days
Class 1
Risk

K182640 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet B.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shandong Hengya Packaging Printing Co.,Ltd (Weifang City, CN). The FDA issued a Cleared decision on April 12, 2019 after a review of 200 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.

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Submission Details

510(k) Number K182640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2018
Decision Date April 12, 2019
Days to Decision 200 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 129d · This submission: 200d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 612
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K182640.
Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs
K182308 · Sri Trang Gloves (Thailand) Co., Ltd. · May 2019
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
K190606 · Kossan International Sdn Bhd · May 2019
Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue)
K182612 · Zibo Yahao Supplies Co., Ltd. · May 2019
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K183287 · Kossan International Sdn Bhd · Apr 2019
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs
K182554 · He Chuang Plastic & Rubber Co., Ltd. · Mar 2019
Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs
K182241 · Sri Trang Gloves (Thailand) Co., Ltd. · Mar 2019