Cleared Traditional

K060724 - POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY)

K060724 is an FDA 510(k) clearance for POWDER FREE NITRILE EXAMINATION GLOVE (..., 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 61-day FDA review.

K060724 · Smart Glove Corp. Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
61d
Days
Class 1
Risk

K060724 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY). 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 17, 2006 after a review of 61 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 - K060724

510(k) Number K060724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2006
Decision Date May 17, 2006
Days to Decision 61 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
68d faster than avg
Panel avg: 129d · This submission: 61d
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 1078
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K060724.
POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BLUE COLOR)
K060726 · Smart Glove Corp. Sdn Bhd · May 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
TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELING
K060073 · Shen Wei (Usa), Inc. · May 2006
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED
K060771 · Kossan Latex Industries(M)Sdn Bhd · May 2006
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K060147 · Hongye Plastic Products Co., Ltd. · Apr 2006