Cleared Traditional

K964148 - PATIENT EXAMINATION GLOVES

Also marketed or referenced as:
CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVES

K964148 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVES, manufactured by Hartalega Sdn Bhd. The device is a Class 1 General Hospital device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K964148

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.

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 908
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K964148.
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
SAFESKIN
K962139 · Safeskin Corp. · Dec 1996
NITRILE COPOLYMER PATIENT EXAMINATION GLOVES
K962518 · P.T. Irama Dinamika Latex · Dec 1996
CHLOROPRENE EXAM GLOVES
K963771 · P.T. Irama Dinamika Latex · Dec 1996