Cleared Traditional

K171667 - Powder Free Nitrile Examination Glove

K171667 is an FDA 510(k) clearance for Powder Free Nitrile Examination Glove, manufactured by Professional Latex Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K171667 · Professional Latex Sdn Bhd · General Hospital
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Sep 2017
Decision
95d
Days
Class 1
Risk

K171667 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Glove. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Professional Latex Sdn Bhd (Kamunting, MY). The FDA issued a Cleared decision on September 8, 2017 after a review of 95 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 Professional Latex Sdn Bhd devices

FDA 510(k) Submission Details - K171667

510(k) Number K171667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2017
Decision Date September 08, 2017
Days to Decision 95 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
34d faster than avg
Panel avg: 129d · This submission: 95d
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 1157
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K171667.
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)
K172015 · Careglove Global Sdn. Bhd. · Sep 2017
Powder Free Nitrile Examination Gloves (Orange)
K171541 · Comfort Rubber Gloves Industries Sdn. Bhd. · Sep 2017
Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs
K171378 · Semperit Investments Asia Pte , Ltd. · Sep 2017
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
K170136 · Shandong Feiyang Professional Gloves Co., Ltd. · Aug 2017
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)
K171104 · Yty Industry (Manjung) Sdn Bhd · Aug 2017
Xingyu Nitrile Powder Free Patient Examination Gloves, White color
K171615 · Shandong Xingyu Gloves Co., Ltd. · Jul 2017