Cleared Traditional

K984356 - NITRILE PATIENT EXAMINATION GLOVE

K984356 is the FDA 510(k) clearance for NITRILE PATIENT EXAMINATION GLOVE by Perusahaan Getah Asas Sdn. Bhd.. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K984356 · Perusahaan Getah Asas Sdn. Bhd. · General Hospital
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Jan 1999
Decision
32d
Days
Class 1
Risk

K984356 is an FDA 510(k) clearance for the NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOWDERED USP). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Perusahaan Getah Asas Sdn. Bhd. (Selangor, Darul Ehsan, MY). The FDA issued a Cleared decision on January 8, 1999 after a review of 32 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Perusahaan Getah Asas Sdn. Bhd. devices

Submission Details

510(k) Number K984356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1998
Decision Date January 08, 1999
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
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 612
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K984356.
POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)
K991511 · Perusahaan Getah Asas Sdn. Bhd. · Jun 1999
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K990283 · Hartalega Sdn Bhd · Mar 1999
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED)
K984605 · Perusahaan Getah Asas Sdn. Bhd. · Jan 1999
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE
K983729 · Perusahaan Getah Asas Sdn. Bhd. · Dec 1998
NITRILE PATIENT EXAMINATION GLOVE
K982440 · Perusahaan Getah Asas Sdn. Bhd. · Sep 1998
POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES
K972090 · Shen Wei (Usa), Inc. · Nov 1997