Cleared Traditional

K981774 - MEDI-PLUS

K981774 is an FDA 510(k) clearance for MEDI-PLUS, manufactured by Pwa Industries Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K981774 · Pwa Industries Sdn. Bhd. · General Hospital
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Jul 1998
Decision
65d
Days
Class 1
Risk

K981774 is an FDA 510(k) clearance for the MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pwa Industries Sdn. Bhd. (Kuantan, Pahang, MY). The FDA issued a Cleared decision on July 24, 1998 after a review of 65 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 Pwa Industries Sdn. Bhd. devices

FDA 510(k) Submission Details - K981774

510(k) Number K981774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1998
Decision Date July 24, 1998
Days to Decision 65 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 129d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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 - LYY Latex Patient Examination Glove

All 294
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K981774.
POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)
K982286 · Besglove Medicare Sdn. Bhd. · Aug 1998
POWDERED GREEN LATEX EXAMINATION GLOVES
K982284 · Besglove Medicare Sdn. Bhd. · Aug 1998
POWDERFREE GREEN LATEX EXAMINATION GLOVES
K982285 · Besglove Medicare Sdn. Bhd. · Aug 1998
SMARTTEX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM
K981347 · Smart Glove Corp. Sdn Bhd · May 1998
SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES
K981348 · Smart Glove Corp. Sdn Bhd · May 1998
SAFETY POWDERED BLUE LATEX EXAMINATION GLOVES
K980939 · Besglove Medicare Sdn. Bhd. · Apr 1998