Cleared Traditional

K053366 - NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE

K053366 is an FDA 510(k) clearance for NITRILE EXAMINATION GLOVES, manufactured by Pt Mahakarya Inti Buana. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K053366 · Pt Mahakarya Inti Buana · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
115d
Days
Class 1
Risk

K053366 is an FDA 510(k) clearance for the NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Pt Mahakarya Inti Buana (Morawa, Sumut, ID). The FDA issued a Cleared decision on March 30, 2006 after a review of 115 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.

View all Pt Mahakarya Inti Buana devices

FDA 510(k) Submission Details - K053366

510(k) Number K053366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2005
Decision Date March 30, 2006
Days to Decision 115 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
14d faster than avg
Panel avg: 129d · This submission: 115d
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 765
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K053366.
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
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL)
K060753 · Siam Sempermed Corp., Ltd. · Apr 2006
NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES
K052502 · Yty Industry (Manjung) Sdn Bhd · Nov 2005
POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE
K052877 · Syntex Healthcare Products Co., Ltd. · Nov 2005
NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E
K052890 · Siam Sempermed Corp., Ltd. · Oct 2005