Cleared Traditional

K060726 - POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BLUE COLOR)

K060726 is an FDA 510(k) clearance for POWDER FREE NITRILE EXAMINATION GLOVE C..., manufactured by Smart Glove Corp. Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K060726 · Smart Glove Corp. Sdn Bhd · General Hospital
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May 2006
Decision
69d
Days
Class 1
Risk

K060726 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BL.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Smart Glove Corp. Sdn Bhd (Selangor Darul Eshan, MY). The FDA issued a Cleared decision on May 25, 2006 after a review of 69 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 Smart Glove Corp. Sdn Bhd devices

FDA 510(k) Submission Details - K060726

510(k) Number K060726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2006
Decision Date May 25, 2006
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
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 1074
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K060726.
NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES
K061553 · Yty Industry (Manjung) Sdn Bhd · Jul 2006
BLUE POWDER FREE NITRILE EXAMINATION GLOVES
K052583 · Hartalega Sdn Bhd · Jun 2006
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR)
K060402 · Brightway Holdings Sdn. Bhd. · Jun 2006
ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES
K061074 · Bright Element Sdn Bhd · May 2006
BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
K061192 · Ethicon Endo-Surgery, LLC · May 2006
POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY)
K060724 · Smart Glove Corp. Sdn Bhd · May 2006