Cleared Traditional

K162381 - HG PRO XP Nitrile Powder Free Examinati...

K162381 is an FDA 510(k) clearance for HG PRO XP Nitrile Powder Free Examinati..., manufactured by Healthy Glove Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K162381 · Healthy Glove Co., Ltd. · General Hospital
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Jan 2017
Decision
160d
Days
Class 1
Risk

K162381 is an FDA 510(k) clearance for the HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemothe.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Healthy Glove Co., Ltd. (Hat Yai, TH). The FDA issued a Cleared decision on January 31, 2017 after a review of 160 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 Healthy Glove Co., Ltd. devices

FDA 510(k) Submission Details - K162381

510(k) Number K162381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2016
Decision Date January 31, 2017
Days to Decision 160 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 129d · This submission: 160d
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 686
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K162381.
Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
K162982 · Medline Industries, Inc. · Feb 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K162491 · Hartalega Sdn Bhd · Feb 2017
NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE
K162923 · Hartalega NGC Sdn. Bhd. · Feb 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
K162818 · Hartalega Sdn Bhd · Jan 2017
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
K162819 · Hartalega Sdn Bhd · Jan 2017
Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)
K162146 · Brightway Holdings Sdn. Bhd. · Jan 2017