Cleared Traditional

K180644 - Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green

K180644 is an FDA 510(k) clearance for Nitrile Powder Free Examination Gloves ..., manufactured by Hartalega Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K180644 · Hartalega Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
151d
Days
Class 1
Risk

K180644 is an FDA 510(k) clearance for the Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green. 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 August 10, 2018 after a review of 151 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

FDA 510(k) Submission Details - K180644

510(k) Number K180644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2018
Decision Date August 10, 2018
Days to Decision 151 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 129d · This submission: 151d
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 907
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K180644.
SBG Black Nitrile Powder Free Medical Examination Glove
K180468 · Showa Best Glove, Inc. · Oct 2018
Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims
K181066 · Eco Medi Glove Sdn. Bhd. · Sep 2018
Biodegradable Nitrile Powder Free Examination Glove (Blue)
K173509 · Hartalega Sdn Bhd · Aug 2018
Nitrile Patient Examination Powder Free Glove, Textured, Black
K161085 · Multisafe Sdn. Bhd. · Jul 2018
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)
K180505 · Hartalega Sdn Bhd · Jun 2018
White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
K180452 · Riverstone Resources Sdn Bhd · Jun 2018