Cleared Traditional

K954533 - ELASTYREN HYPOALLERGENIC PATIENT EXAMINATION GLOVES

K954533 is an FDA 510(k) clearance for ELASTYREN HYPOALLERGENIC PATIENT EXAMIN..., 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 73-day FDA review.

K954533 · Eci Medical Technologies, Inc. · General Hospital
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Dec 1995
Decision
73d
Days
Class 1
Risk

K954533 is an FDA 510(k) clearance for the ELASTYREN HYPOALLERGENIC PATIENT EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Eci Medical Technologies, Inc. (Richmondhill, Ontario, CA). The FDA issued a Cleared decision on December 11, 1995 after a review of 73 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.

View all Eci Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K954533

510(k) Number K954533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1995
Decision Date December 11, 1995
Days to Decision 73 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 129d · This submission: 73d
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 779
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K954533.
SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES)
K952051 · Wembley Rubber Products (M) Sdn Bhd · Dec 1995
SCINITREX POWER FREE BLUE NITRILE EXAMINATION GLOVES
K952154 · Wembley Rubber Products (M) Sdn Bhd · Dec 1995
SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES
K952155 · Wembley Rubber Products (M) Sdn Bhd · Dec 1995
SCINITREX (GREEN POWDERED NITRILE EXAMINATION GLOVES)
K951921 · Wembley Rubber Products (M) Sdn Bhd · Oct 1995
SCINITREX (POWDERED NITRILE EXAMINATION GLOVESD)
K952052 · Wembley Rubber Products (M) Sdn Bhd · Oct 1995
DISPOSABLE POLY GLOVES
K841676 · Abco Dealers, Inc. · May 1984