Cleared Traditional

K983334 - NITRILE POWDER FREE EXAMINATION GLOVES

K983334 is an FDA 510(k) clearance for NITRILE POWDER FREE EXAMINATION GLOVES, manufactured by Cranberry (M) Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K983334 · Cranberry (M) Sdn. Bhd. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 1999
Decision
149d
Days
Class 1
Risk

K983334 is an FDA 510(k) clearance for the NITRILE POWDER FREE EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Cranberry (M) Sdn. Bhd. (Ipoh Perak, MY). The FDA issued a Cleared decision on February 19, 1999 after a review of 149 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 Cranberry (M) Sdn. Bhd. devices

FDA 510(k) Submission Details - K983334

510(k) Number K983334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1998
Decision Date February 19, 1999
Days to Decision 149 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
20d slower than avg
Panel avg: 129d · This submission: 149d
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 803
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K983334.
LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)
K990420 · La Glove (M) Sdn. Bhd. · Mar 1999
EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES
K990013 · Yty Industry (Manjung) Sdn Bhd · Mar 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
NITRIKLEEN- NITRILE EXAMINATION GLOVE POWDER FREE
K983828 · Sinetimed Latex Sdn Bhd · Jan 1999
NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOWDERED USP)
K984356 · Perusahaan Getah Asas Sdn. Bhd. · Jan 1999