Cleared Traditional

K052955 - NITRILE BLUE POWDERED EXAMINATION GLOVES

K052955 is an FDA 510(k) clearance for NITRILE BLUE POWDERED EXAMINATION GLOVES, manufactured by Great Glove Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K052955 · Great Glove Sdn Bhd · General Hospital
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Jan 2006
Decision
90d
Days
Class 1
Risk

K052955 is an FDA 510(k) clearance for the NITRILE BLUE POWDERED EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Great Glove Sdn Bhd (Klang, Selangor, MY). The FDA issued a Cleared decision on January 19, 2006 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K052955

510(k) Number K052955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2005
Decision Date January 19, 2006
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 1177
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K052955.
SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44
K060733 · Barriermed, Inc. · Apr 2006
NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE
K053366 · Pt Mahakarya Inti Buana · Mar 2006
POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
K053657 · Pt Mahakarya Inti Buana · Feb 2006
NITRILE BLUE POWDER FREE EXAMINATION GLOVE
K052956 · Great Glove Sdn Bhd · Dec 2005
SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55
K052892 · Barriermed Glove Co. · Nov 2005
NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES
K052502 · Yty Industry (Manjung) Sdn Bhd · Nov 2005
K052955 · NITRILE BLUE POWDERED EXAMINATION GLOVES
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