Cleared Traditional

K182554 - Powder Free Nitrile Examination Gloves

K182554 is the FDA 510(k) clearance for Powder Free Nitrile Examination Gloves by He Chuang Plastic & Rubber Co., Ltd.. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K182554 · He Chuang Plastic & Rubber Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
186d
Days
Class 1
Risk

K182554 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherap.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by He Chuang Plastic & Rubber Co., Ltd. (Zibo, CN). The FDA issued a Cleared decision on March 22, 2019 after a review of 186 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.

View all He Chuang Plastic & Rubber Co., Ltd. devices

Submission Details

510(k) Number K182554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2018
Decision Date March 22, 2019
Days to Decision 186 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
57d slower than avg
Panel avg: 129d · This submission: 186d
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 K182554.
Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue)
K182612 · Zibo Yahao Supplies Co., Ltd. · May 2019
Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)
K182640 · Shandong Hengya Packaging Printing Co.,Ltd · Apr 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
Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs
K182241 · Sri Trang Gloves (Thailand) Co., Ltd. · Mar 2019
Powder Free Nitrile Patient Examination Gloves, Blue Color
K181106 · Jiangsu Dongxin Medical Technology Co., Ltd. · Jan 2019
Nitrile Glove Powder Free White
K183068 · Haining Medical Products Co., Ltd. · Dec 2018