Cleared Traditional

K180786 - Sterile Nitrile Powder Free Examination...

K180786 is the FDA 510(k) clearance for Sterile Nitrile Powder Free Examination... by Hartalega Sdn Bhd. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K180786 · Hartalega Sdn Bhd · General Hospital
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Nov 2018
Decision
221d
Days
Class 1
Risk

K180786 is an FDA 510(k) clearance for the Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherap.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Hartalega Sdn Bhd (Bandar Sri Damansara, MY). The FDA issued a Cleared decision on November 2, 2018 after a review of 221 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 Hartalega Sdn Bhd devices

Submission Details

510(k) Number K180786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2018
Decision Date November 02, 2018
Days to Decision 221 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
92d slower than avg
Panel avg: 129d · This submission: 221d
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 554
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K180786.
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K181857 · Kossan International Sdn Bhd · Nov 2018
Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)
K180645 · Hartalega Sdn Bhd · Nov 2018
Nitrile Glove Powder Free Black
K182528 · Haining Medical Products Co., Ltd. · Nov 2018
Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs
K182096 · Owens & Minor Halyard, Inc. · Nov 2018
SBG Blue Nitrile Powder Free Medical Examination Glove
K180467 · Showa Best Glove, Inc. · Oct 2018
SBG Black Nitrile Powder Free Medical Examination Glove
K180468 · Showa Best Glove, Inc. · Oct 2018