Cleared Traditional

K200960 - Medline Powder Free Examination Gloves ...

K200960 is an FDA 510(k) clearance for Medline Powder Free Examination Gloves ..., manufactured by Medline Industires, Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K200960 · Medline Industires, Inc. · General Hospital
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Jul 2020
Decision
94d
Days
Class 1
Risk

K200960 is an FDA 510(k) clearance for the Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Medline Industires, Inc. (Northfiled, US). The FDA issued a Cleared decision on July 13, 2020 after a review of 94 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 Industires, Inc. devices

FDA 510(k) Submission Details - K200960

510(k) Number K200960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2020
Decision Date July 13, 2020
Days to Decision 94 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
35d faster than avg
Panel avg: 129d · This submission: 94d
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 684
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K200960.
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)
K201530 · Hartalega NGC Sdn. Bhd. · Aug 2020
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
K201531 · Hartalega Sdn Bhd · Aug 2020
Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff
K193666 · Medline Industries, Inc. · Aug 2020
Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
K192954 · Comfort Rubber Gloves Industries Sdn. Bhd. · Jun 2020
Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for
K200671 · Ansell Healthcare Products, LLC · Jun 2020
mCare(R) Powder Free Nitrile Orange Examination Gloves
K200967 · Mercator Medical (Thailand), Ltd. · Jun 2020