Cleared Traditional

K893606 - PATIENT EXAMINATION GLOVES

K893606 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVES, manufactured by Aukland Mfg., Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K893606 · Aukland Mfg., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
303d
Days
Class 1
Risk

K893606 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Aukland Mfg., Inc. (Cary, US). The FDA issued a Cleared decision on March 9, 1990 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Aukland Mfg., Inc. devices

FDA 510(k) Submission Details - K893606

510(k) Number K893606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1989
Decision Date March 09, 1990
Days to Decision 303 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 129d · This submission: 303d
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 1104
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K893606.
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