Cleared Traditional

K180452 - White Nitrile Examination Glove

K180452 is an FDA 510(k) clearance for White Nitrile Examination Glove, manufactured by Riverstone Resources Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K180452 · Riverstone Resources Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
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Jun 2018
Decision
112d
Days
Class 1
Risk

K180452 is an FDA 510(k) clearance for the White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Riverstone Resources Sdn Bhd (Bukit Beruntung, MY). The FDA issued a Cleared decision on June 12, 2018 after a review of 112 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 Riverstone Resources Sdn Bhd devices

FDA 510(k) Submission Details - K180452

510(k) Number K180452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2018
Decision Date June 12, 2018
Days to Decision 112 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 129d · This submission: 112d
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 682
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K180452.
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
K180644 · 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
Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color
K171422 · Ever Global (Vietnam) Enterprise Corp · Jun 2018
Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange
K172867 · Gmp Medicare Sdn Bhd (F25) · May 2018
Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs)
K180696 · Medline Industries, Inc. · Apr 2018