Cleared Traditional

K024083 - GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR

K024083 is an FDA 510(k) clearance for GREEN POWDER FREE NITRILE MEDICAL EXAMI..., manufactured by Supermax Glove Manufacturing Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K024083 · Supermax Glove Manufacturing Sdn Bhd · General Hospital
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Jan 2003
Decision
30d
Days
Class 1
Risk

K024083 is an FDA 510(k) clearance for the GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Supermax Glove Manufacturing Sdn Bhd (Sungai Buloh, Selangor, MY). The FDA issued a Cleared decision on January 10, 2003 after a review of 30 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Supermax Glove Manufacturing Sdn Bhd devices

FDA 510(k) Submission Details - K024083

510(k) Number K024083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2002
Decision Date January 10, 2003
Days to Decision 30 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
99d faster than avg
Panel avg: 129d · This submission: 30d
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 964
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K024083.
ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED
K030335 · Perusahaan Getah Asas Sdn. Bhd. · Mar 2003
POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR
K023072 · Arista Latindo Industrial Ltd. P.T · Feb 2003
POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED
K024184 · Perusahaan Getah Asas Sdn. Bhd. · Jan 2003
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR
K024025 · Kossan Latex Industries(M)Sdn Bhd · Dec 2002
DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE
K023517 · Wrp Asia Pacific Sdn. Bhd. · Dec 2002
FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES
K022671 · Hartalega Sdn Bhd · Nov 2002