Cleared Traditional

K151997 - Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)

K151997 is an FDA 510(k) clearance for Nitrile Powder Free Examination Gloves ..., manufactured by Hartalega NGC Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K151997 · Hartalega NGC Sdn. Bhd. · General Hospital
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Mar 2016
Decision
255d
Days
Class 1
Risk

K151997 is an FDA 510(k) clearance for the Nitrile 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 Hartalega NGC Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on March 31, 2016 after a review of 255 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.

FDA 510(k) Submission Details - K151997

510(k) Number K151997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2015
Decision Date March 31, 2016
Days to Decision 255 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 129d · This submission: 255d
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 1180
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K151997.
Nitrile Patient Examination gloves, Powderfree, Blue color
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Powder Free Polychloroprene Examination Glove Green
K153510 · Terang Nusa Sdn Bhd · Mar 2016
Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color
K152705 · Jiayuan Medical Products Co., Ltd. · Mar 2016
K151997 · Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)
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