Cleared Traditional

K051317 - POLYMER COATED POWDER FREE NITRILE EXAM...

K051317 is the FDA 510(k) clearance for POLYMER COATED POWDER FREE NITRILE EXAM... by Platinum Glove Industries Sdn. Bhd.. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K051317 · Platinum Glove Industries Sdn. Bhd. · General Hospital
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Jun 2005
Decision
31d
Days
Class 1
Risk

K051317 is an FDA 510(k) clearance for the POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE .... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Platinum Glove Industries Sdn. Bhd. (Kuala Lumpur, MY). The FDA issued a Cleared decision on June 20, 2005 after a review of 31 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 Platinum Glove Industries Sdn. Bhd. devices

Submission Details

510(k) Number K051317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2005
Decision Date June 20, 2005
Days to Decision 31 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 129d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 584
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K051317.
NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E
K052890 · Siam Sempermed Corp., Ltd. · Oct 2005
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)
K051777 · Hartalega Sdn Bhd · Aug 2005
NITRILE POWDERED EXAMINATION GLOVES (BLUE)
K051778 · Hartalega Sdn Bhd · Jul 2005
KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE
K051347 · Kimberly-Clark Corp. · Jun 2005
POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN
K050467 · Shen Wei (Usa), Inc. · Mar 2005
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)
K050214 · Hartalega Sdn Bhd · Mar 2005