Cleared Traditional

K980966 - SUPERGLOVES POWDERED NITRILE

K980966 is an FDA 510(k) clearance for SUPERGLOVES POWDERED NITRILE, manufactured by Supermax Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K980966 · Supermax Sdn Bhd · General Hospital
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Jul 1998
Decision
128d
Days
Class 1
Risk

K980966 is an FDA 510(k) clearance for the SUPERGLOVES POWDERED NITRILE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Supermax Sdn Bhd (Sungai Pelong, Selangor, MY). The FDA issued a Cleared decision on July 22, 1998 after a review of 128 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Supermax Sdn Bhd devices

FDA 510(k) Submission Details - K980966

510(k) Number K980966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1998
Decision Date July 22, 1998
Days to Decision 128 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
1d faster than avg
Panel avg: 129d · This submission: 128d
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 808
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K980966.
POWDERFREE GREEN NITRILE EXAMINATION GLOVES
K981673 · Besglove Medicare Sdn. Bhd. · Jul 1998
POWDERED GREEN NITRILE EXAMINATION GLOVES
K981674 · Besglove Medicare Sdn. Bhd. · Jul 1998
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)
K981675 · Besglove Medicare Sdn. Bhd. · Jul 1998
NITRILON CORRECT-TOUCH
K981304 · Ct Intl. · Jun 1998
NITRILON CORRECT-TOUCH
K981333 · Biopro (M) Sdn Bhd · Jun 1998
POWDERED NITRILE EXAMINATION GLOVES
K981133 · Servicom Services Sdn Bhd · Jun 1998