Cleared Traditional

K990841 - NUGARD NITRIL NITRILE EXAMINATION GLOVE

K990841 is an FDA 510(k) clearance for NUGARD NITRIL NITRILE EXAMINATION GLOVE, manufactured by Terang Nusa Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K990841 · Terang Nusa Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
63d
Days
Class 1
Risk

K990841 is an FDA 510(k) clearance for the NUGARD NITRIL NITRILE EXAMINATION GLOVE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Terang Nusa Sdn Bhd (Kota Bharu, MY). The FDA issued a Cleared decision on May 17, 1999 after a review of 63 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 Terang Nusa Sdn Bhd devices

FDA 510(k) Submission Details - K990841

510(k) Number K990841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1999
Decision Date May 17, 1999
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
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 K990841.
POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)
K991511 · Perusahaan Getah Asas Sdn. Bhd. · Jun 1999
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)
K990878 · Brightway Holdings Sdn. Bhd. · May 1999
NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE
K990840 · Terang Nusa Sdn Bhd · May 1999
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)
K990541 · Brightway Holdings Sdn. Bhd. · Apr 1999
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
K990542 · Brightway Holdings Sdn. Bhd. · Apr 1999
EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES
K990013 · Yty Industry (Manjung) Sdn Bhd · Mar 1999