Cleared Traditional

K192315 - Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)

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

K192315 · Medline Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K192315

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.

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 1007
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