Cleared Traditional

K981039 - POWDERFREE GREEN NITRILE EXAMINATION GL...

K981039 is an FDA 510(k) clearance for POWDERFREE GREEN NITRILE EXAMINATION GL..., manufactured by Sri Johani Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K981039 · Sri Johani Sdn. Bhd. · General Hospital
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Apr 1998
Decision
33d
Days
Class 1
Risk

K981039 is an FDA 510(k) clearance for the POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Sri Johani Sdn. Bhd. (Selangor, MY). The FDA issued a Cleared decision on April 21, 1998 after a review of 33 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 Sri Johani Sdn. Bhd. devices

FDA 510(k) Submission Details - K981039

510(k) Number K981039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1998
Decision Date April 21, 1998
Days to Decision 33 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
96d faster than avg
Panel avg: 129d · This submission: 33d
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 682
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K981039.
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
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES
K981349 · Smart Glove Corp. Sdn Bhd · May 1998
NITRILE PRE-POWDERED EXAMINATION GLOVES
K974907 · Smart Glove Corp. Sdn Bhd · Mar 1998
POWDERED GREEN NITRILE EXAMINATION GLOVES
K974886 · Sri Johani Sdn. Bhd. · Jan 1998
POWDERFREE GREEN NITRILE EXAMINATION GLOVES
K974887 · Sri Johani Sdn. Bhd. · Jan 1998