Cleared Traditional

K980149 - POWDERED NITRILE EXAMINATION GLOVES

K980149 is an FDA 510(k) clearance for POWDERED NITRILE EXAMINATION GLOVES, manufactured by Masju Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K980149 · Masju Sdn. Bhd. · General Hospital
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Jan 1998
Decision
13d
Days
Class 1
Risk

K980149 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 Masju Sdn. Bhd. (Sungai Petani, MY). The FDA issued a Cleared decision on January 29, 1998 after a review of 13 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 Masju Sdn. Bhd. devices

FDA 510(k) Submission Details - K980149

510(k) Number K980149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1998
Decision Date January 29, 1998
Days to Decision 13 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 129d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Tuv Product Service, Inc.
CAROLE STAMP

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 803
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K980149.
POWDER-FREE NITRILE EXAMINATION GLOVES
K980150 · Masju Sdn. Bhd. · 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
DASH, VITAL GARD
K974114 · Dash Medical Gloves Sdn Bhd · Dec 1997
POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K974183 · Sri Johani Sdn. Bhd. · Dec 1997
POLYMER NITRILE EXAMINATION GLOVES
K974185 · Sri Johani Sdn. Bhd. · Dec 1997

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.