Cleared Traditional

K984311 - NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE

K984311 is an FDA 510(k) clearance for NBR4 MILS NITRILE POWDER FREE EXAMINATI..., manufactured by Sumirubber Industries (Kedah) Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K984311 · Sumirubber Industries (Kedah) Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
69d
Days
Class 1
Risk

K984311 is an FDA 510(k) clearance for the NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Sumirubber Industries (Kedah) Sdn. Bhd. (Sungai Petani, Kedah, MY). The FDA issued a Cleared decision on February 9, 1999 after a review of 69 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 Sumirubber Industries (Kedah) Sdn. Bhd. devices

FDA 510(k) Submission Details - K984311

510(k) Number K984311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1998
Decision Date February 09, 1999
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
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 1029
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K984311.
NITRILE POWDER FREE EXAMINATION GLOVES
K983334 · Cranberry (M) Sdn. Bhd. · Feb 1999
POWDERED NITRILE EXAMINATION GLOVES
K984615 · Shiva Medicare , Ltd. · Feb 1999
NBR 4 MILS, NITRILE EXAMINATION GLOVE NON-STERILE POWDERED
K984309 · Sumirubber Industries (Kedah) Sdn. Bhd. · Feb 1999
POWDER FREE NITRILE EXAMINATION GLOVES
K984610 · Shiva Medicare , Ltd. · Feb 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