Cleared Abbreviated

K060753 - NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL)

K060753 is an FDA 510(k) clearance for NON-STERILE, manufactured by Siam Sempermed Corp., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Abbreviated 510(k) pathway after a 37-day FDA review.

K060753 · Siam Sempermed Corp., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
37d
Days
Class 1
Risk

K060753 is an FDA 510(k) clearance for the NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Siam Sempermed Corp., Ltd. (Clearwater, US). The FDA issued a Cleared decision on April 27, 2006 after a review of 37 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K060753

510(k) Number K060753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2006
Decision Date April 27, 2006
Days to Decision 37 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 129d · This submission: 37d
Pathway characteristics
Standards-based clearance path.

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 1176
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K060753.
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
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
K060753 · NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL)
Download PDF FDA Summary Siam Sempermed Corp.,…