Cleared Traditional

K971356 - POWDER FREE SYNTHETIC EXAMINATION GLOVES

K971356 is an FDA 510(k) clearance for POWDER FREE SYNTHETIC EXAMINATION GLOVES, manufactured by Arista Latindo Industrial Ltd. P.T. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K971356 · Arista Latindo Industrial Ltd. P.T · General Hospital
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Sep 1997
Decision
147d
Days
Class 1
Risk

K971356 is an FDA 510(k) clearance for the POWDER FREE SYNTHETIC EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Arista Latindo Industrial Ltd. P.T (Jakarta Barat, ID). The FDA issued a Cleared decision on September 5, 1997 after a review of 147 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 Arista Latindo Industrial Ltd. P.T devices

FDA 510(k) Submission Details - K971356

510(k) Number K971356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1997
Decision Date September 05, 1997
Days to Decision 147 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
18d slower than avg
Panel avg: 129d · This submission: 147d
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 705
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K971356.
PATIENT NITRILE EXAMINATION GLOVE (POWDERFREE)
K973058 · Sri Johani Sdn. Bhd. · Nov 1997
PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
K973059 · Sri Johani Sdn. Bhd. · Nov 1997
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
PATIENT EXAMINATION GLOVES
K964148 · Hartalega Sdn Bhd · Feb 1997