Cleared Traditional

K193666 - Powder-Free Blue Nitrile Examination Gl...

Also marketed or referenced as:
Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff

K193666 is the FDA 510(k) clearance for Powder-Free Blue Nitrile Examination Gl... by Medline Industries, Inc.. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K193666 · Medline Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
217d
Days
Class 1
Risk

K193666 is an FDA 510(k) clearance for the Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy.... 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 August 4, 2020 after a review of 217 days - an extended review cycle.

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 K193666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2019
Decision Date August 04, 2020
Days to Decision 217 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
88d slower than avg
Panel avg: 129d · This submission: 217d
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 K193666.
Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug
K200093 · Anhui Lntco Medical Products Co., Ltd. · Aug 2020
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
Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)
K200960 · Medline Industires, Inc. · Jul 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