Cleared Traditional

K060733 - SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44

K060733 is an FDA 510(k) clearance for SYNTHALON PI POWDER-FREE SYNTHETIC POLY..., manufactured by Barriermed, Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K060733 · Barriermed, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 2006
Decision
35d
Days
Class 1
Risk

K060733 is an FDA 510(k) clearance for the SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION G.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Barriermed, Inc. (Lake Mary, US). The FDA issued a Cleared decision on April 24, 2006 after a review of 35 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.

FDA 510(k) Submission Details - K060733

510(k) Number K060733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2006
Decision Date April 24, 2006
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
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 1181
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K060733.
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
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL)
K060753 · Siam Sempermed Corp., Ltd. · 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 POWDERED EXAMINATION GLOVES
K052955 · Great Glove Sdn Bhd · Jan 2006
K060733 · SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44
Download PDF Barriermed, Inc.