Cleared Traditional

K022814 - MULTIPLE NITRILE EXAMINATION GLOVES (PO...

K022814 is an FDA 510(k) clearance for MULTIPLE NITRILE EXAMINATION GLOVES (PO..., manufactured by Pt. Smartglove Indonesia. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K022814 · Pt. Smartglove Indonesia · General Hospital
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Feb 2003
Decision
177d
Days
Class 1
Risk

K022814 is an FDA 510(k) clearance for the MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Pt. Smartglove Indonesia (Tg Morawa-Deli Serdang Utara, ID). The FDA issued a Cleared decision on February 19, 2003 after a review of 177 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 Pt. Smartglove Indonesia devices

FDA 510(k) Submission Details - K022814

510(k) Number K022814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2002
Decision Date February 19, 2003
Days to Decision 177 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 129d · This submission: 177d
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 750
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K022814.
MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA POLYURETHANE G
K031384 · Yty Industry (Manjung) Sdn Bhd · Jun 2003
NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR
K030245 · Arista Latindo Industrial Ltd. P.T · Apr 2003
ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED
K030335 · Perusahaan Getah Asas Sdn. Bhd. · Mar 2003
POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR
K023072 · Arista Latindo Industrial Ltd. P.T · Feb 2003
POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED
K024184 · Perusahaan Getah Asas Sdn. Bhd. · Jan 2003
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR
K024025 · Kossan Latex Industries(M)Sdn Bhd · Dec 2002