Cleared Traditional

K192104 - Medline Sterile Power-Free Nitrile Exam...

K192104 is the FDA 510(k) clearance for Medline Sterile Power-Free Nitrile Exam... by Medline Industries, Inc.. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K192104 · Medline Industries, Inc. · General Hospital
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Dec 2019
Decision
140d
Days
Class 1
Risk

K192104 is an FDA 510(k) clearance for the Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use wi.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on December 23, 2019 after a review of 140 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K192104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2019
Decision Date December 23, 2019
Days to Decision 140 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
11d slower than avg
Panel avg: 129d · This submission: 140d
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 583
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K192104.
mCare® Powder Free Nitrile Black Examination Glove
K192444 · Mercator Medical (Thailand), Ltd. · Dec 2019
Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs
K190736 · Ever Growth (Vietnam) Co. , Ltd. · Dec 2019
Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color
K190860 · Ever Growth (Vietnam) Co. , Ltd. · Dec 2019
Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White
K190725 · Riverstone Resources Sdn Bhd · Dec 2019
mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
K190876 · Mercator Medical (Thailand), Ltd. · Dec 2019
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)
K192232 · Hartalega NGC Sdn. Bhd. · Nov 2019