Cleared Traditional

K083624 - POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES

K083624 is an FDA 510(k) clearance for POWDER FREE NITRILE (BLUE AND WHITE) EX..., manufactured by Comfort Rubber Gloves Ind. Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K083624 · Comfort Rubber Gloves Ind. Sdn. Bhd. · General Hospital
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Feb 2009
Decision
64d
Days
Class 1
Risk

K083624 is an FDA 510(k) clearance for the POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Comfort Rubber Gloves Ind. Sdn. Bhd. (Taiping, Perak, MY). The FDA issued a Cleared decision on February 10, 2009 after a review of 64 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 Comfort Rubber Gloves Ind. Sdn. Bhd. devices

FDA 510(k) Submission Details - K083624

510(k) Number K083624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2008
Decision Date February 10, 2009
Days to Decision 64 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
65d faster than avg
Panel avg: 129d · This submission: 64d
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 799
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K083624.
POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN
K091151 · Gx Corporation Sdn Bhd · Jun 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS
K082957 · Siam Sempermed Corp., Ltd. · May 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS
K083755 · Siam Sempermed Corp., Ltd. · Mar 2009
POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK
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