Cleared Traditional

K192315 - Medline Green Ambidextrous Power-Free N...

K192315 is the FDA 510(k) clearance for Medline Green Ambidextrous Power-Free N... by Medline Industries, Inc.. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K192315 · Medline Industries, Inc. · General Hospital
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Jan 2020
Decision
137d
Days
Class 1
Risk

K192315 is an FDA 510(k) clearance for the Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloid.... 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 January 10, 2020 after a review of 137 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 K192315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2019
Decision Date January 10, 2020
Days to Decision 137 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
8d slower than avg
Panel avg: 129d · This submission: 137d
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 K192315.
Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K192241 · O&M Haylard, Inc. · Mar 2020
Blue Nitrile Examination Gloves Powder Free
K192333 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Jan 2020
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)
K192635 · Wrp Asia Pacific Sdn. Bhd. · Jan 2020
Disposable Powder Free Nitrile Examination Glove, Pink/Black Color
K190942 · Ever Growth (Vietnam) Co. , Ltd. · Jan 2020
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