Cleared Traditional

K892771 - PATIENT EXAMINATION GLOVES (POLY)

K892771 is the FDA 510(k) clearance for PATIENT EXAMINATION GLOVES (POLY) by P.A. Research Corp.. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K892771 · P.A. Research Corp. · General Hospital
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Sep 1989
Decision
155d
Days
Class 1
Risk

K892771 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVES (POLY). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by P.A. Research Corp. (Linden, US). The FDA issued a Cleared decision on September 13, 1989 after a review of 155 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 P.A. Research Corp. devices

Submission Details

510(k) Number K892771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1989
Decision Date September 13, 1989
Days to Decision 155 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
26d slower than avg
Panel avg: 129d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 613
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K892771.
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