Cleared Traditional

K964148 - PATIENT EXAMINATION GLOVES

Also marketed or referenced as:
CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVES

K964148 is the FDA 510(k) clearance for PATIENT EXAMINATION GLOVES by Hartalega Sdn Bhd. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K964148 · Hartalega Sdn Bhd · General Hospital
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Feb 1997
Decision
114d
Days
Class 1
Risk

K964148 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 Hartalega Sdn Bhd (Kuala Lumpur, MY). The FDA issued a Cleared decision on February 7, 1997 after a review of 114 days - within the typical 510(k) review window.

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 Hartalega Sdn Bhd devices

Submission Details

510(k) Number K964148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1996
Decision Date February 07, 1997
Days to Decision 114 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
15d faster than avg
Panel avg: 129d · This submission: 114d
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 554
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K964148.
POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES
K972090 · Shen Wei (Usa), Inc. · Nov 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
NITRILE POWDER-FREE PATIENT EXAMINATION GLOVES
K962461 · Shen Wei (Usa), Inc. · Aug 1996
SCINITREX (POWDER FREE GREEN NITRILE EXAMINATION GLOVES
K951938 · Wembley Rubber Products (M) Sdn Bhd · Dec 1995
SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES)
K952051 · Wembley Rubber Products (M) Sdn Bhd · Dec 1995