Cleared Traditional

K970015 - ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES

K970015 is an FDA 510(k) clearance for ELASTYREN POWDER-FREE PATIENT EXAMINATI..., manufactured by Eci Medical Technologies, Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K970015 · Eci Medical Technologies, Inc. · General Hospital
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Jun 1997
Decision
173d
Days
Class 1
Risk

K970015 is an FDA 510(k) clearance for the ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Eci Medical Technologies, Inc. (Bridgewater, Nova Scotia, CA). The FDA issued a Cleared decision on June 24, 1997 after a review of 173 days - an extended review 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: 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 Eci Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K970015

510(k) Number K970015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1997
Decision Date June 24, 1997
Days to Decision 173 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
44d slower than avg
Panel avg: 129d · This submission: 173d
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 777
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K970015.
POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K972195 · Absolute Synthetic Technologies Malaysia Sdn. Bhd. · Jul 1997
SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES
K971666 · Sj Medical Products (M) Sdn Bhd · Jul 1997
SMART - FIT, POWDERFREE NITRILE EXAMINATION GLOVES
K971665 · Sj Medical Products (M) Sdn Bhd · Jun 1997
NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
K965095 · Ansell Edmont Industrial, Inc. · Apr 1997
PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES
K963804 · Hartalega Sdn Bhd · Feb 1997
NITRILE POWDER-FREE EXAMINATION GLOVES
K964628 · Shen Wei (Usa), Inc. · Feb 1997