Cleared Traditional

K980511 - NITRILE EXAMINATION GLOVES - POWDER FREE

K980511 is an FDA 510(k) clearance for NITRILE EXAMINATION GLOVES - POWDER FREE, manufactured by Influx Pacific Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K980511 · Influx Pacific Sdn. Bhd. · General Hospital
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Mar 1998
Decision
31d
Days
Class 1
Risk

K980511 is an FDA 510(k) clearance for the NITRILE EXAMINATION GLOVES - POWDER FREE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Influx Pacific Sdn. Bhd. (Malacca, West Malaysia, MY). The FDA issued a Cleared decision on March 13, 1998 after a review of 31 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 Influx Pacific Sdn. Bhd. devices

FDA 510(k) Submission Details - K980511

510(k) Number K980511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1998
Decision Date March 13, 1998
Days to Decision 31 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
98d faster than avg
Panel avg: 129d · This submission: 31d
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 779
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K980511.
POWDERFREE BLUE NITRILE EXAMINATION GLOVES (POLYMER COATED)
K980275 · Besglove Medicare Sdn. Bhd. · Mar 1998
POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K980280 · Besglove Medicare Sdn. Bhd. · Mar 1998
POWDERFREE BLUE NITRILE EXAMINATION GLOVES
K980285 · Besglove Medicare Sdn. Bhd. · Mar 1998
NITRILE EXAM GLOVE, POWDER-FREE/WHITE AND BLUE
K974710 · Sinochem Ningbo Latex Gloves Factory · Feb 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