Cleared Traditional

K081972 - BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES

K081972 is an FDA 510(k) clearance for BIOCLEAN CHEMO EMERALD POWDER FREE NITR..., manufactured by Nitritex (M) Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K081972 · Nitritex (M) Sdn. Bhd. · General Hospital
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Dec 2008
Decision
154d
Days
Class 1
Risk

K081972 is an FDA 510(k) clearance for the BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Nitritex (M) Sdn. Bhd. (Kuala Langat, Selangor De, MY). The FDA issued a Cleared decision on December 11, 2008 after a review of 154 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 Nitritex (M) Sdn. Bhd. devices

FDA 510(k) Submission Details - K081972

510(k) Number K081972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2008
Decision Date December 11, 2008
Days to Decision 154 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 129d · This submission: 154d
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 810
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K081972.
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS
K083755 · Siam Sempermed Corp., Ltd. · Mar 2009
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K083717 · Gx Corporation Sdn Bhd · Jan 2009
NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE
K081911 · Siam Sempermed Corp., Ltd. · Jan 2009
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM
K082302 · Pt. Medisafe Technologies · Dec 2008
MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE
K081594 · Medline Industries, Inc. · Oct 2008
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
K082370 · Smart Glove Corp. Sdn Bhd · Oct 2008