Cleared Traditional

K963804 - PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES

K963804 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVES : NITRILE EX..., 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 140-day FDA review.

K963804 · Hartalega Sdn Bhd · General Hospital
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Feb 1997
Decision
140d
Days
Class 1
Risk

K963804 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVES : NITRILE 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 10, 1997 after a review of 140 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 - K963804

510(k) Number K963804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1996
Decision Date February 10, 1997
Days to Decision 140 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
11d slower than avg
Panel avg: 129d · This submission: 140d
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 K963804.
SMART - FIT, POWDERFREE NITRILE EXAMINATION GLOVES
K971665 · Sj Medical Products (M) Sdn Bhd · Jun 1997
ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES
K970015 · Eci Medical Technologies, Inc. · Jun 1997
NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
K965095 · Ansell Edmont Industrial, Inc. · Apr 1997
NITRILE POWDER-FREE EXAMINATION GLOVES
K964628 · Shen Wei (Usa), Inc. · Feb 1997
PATIENT EXAMINATION GLOVES
K964148 · Hartalega Sdn Bhd · Feb 1997
SAFESKIN
K962139 · Safeskin Corp. · Dec 1996