Cleared Traditional

K984615 - POWDERED NITRILE EXAMINATION GLOVES

K984615 is an FDA 510(k) clearance for POWDERED NITRILE EXAMINATION GLOVES, manufactured by Shiva Medicare , Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K984615 · Shiva Medicare , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
50d
Days
Class 1
Risk

K984615 is an FDA 510(k) clearance for the POWDERED NITRILE EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shiva Medicare , Ltd. (Baltimore, US). The FDA issued a Cleared decision on February 17, 1999 after a review of 50 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.

FDA 510(k) Submission Details - K984615

510(k) Number K984615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1998
Decision Date February 17, 1999
Days to Decision 50 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 129d · This submission: 50d
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 1177
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K984615.
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K990283 · Hartalega Sdn Bhd · Mar 1999
NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
K990453 · Alliance Rubber Products Sdn. Bhd. · Mar 1999
NITRILE POWDER FREE EXAMINATION GLOVES
K983334 · Cranberry (M) Sdn. Bhd. · Feb 1999
NBR 4 MILS, NITRILE EXAMINATION GLOVE NON-STERILE POWDERED
K984309 · Sumirubber Industries (Kedah) Sdn. Bhd. · Feb 1999
NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE
K984311 · Sumirubber Industries (Kedah) Sdn. Bhd. · Feb 1999
POWDER FREE NITRILE EXAMINATION GLOVES
K984610 · Shiva Medicare , Ltd. · Feb 1999
K984615 · POWDERED NITRILE EXAMINATION GLOVES
Download PDF FDA Summary Shiva Medicare , Ltd.