Cleared Traditional

K981347 - SMARTTEX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM

K981347 is an FDA 510(k) clearance for SMARTTEX POWDER FREE LATEX EXAMINATION ..., manufactured by Smart Glove Corp. Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K981347 · Smart Glove Corp. Sdn Bhd · General Hospital
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May 1998
Decision
38d
Days
Class 1
Risk

K981347 is an FDA 510(k) clearance for the SMARTTEX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Smart Glove Corp. Sdn Bhd (Klang Selangor, MY). The FDA issued a Cleared decision on May 18, 1998 after a review of 38 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 Smart Glove Corp. Sdn Bhd devices

FDA 510(k) Submission Details - K981347

510(k) Number K981347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1998
Decision Date May 18, 1998
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
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 690
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K981347.
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES
K981062 · Ideal Quality Sdn., Bhd. · Jun 1998
SKINGARD TPF/AOSSTEX TPF/SENSIFREE/ESSENTIAL TPF/AMERIGLO TPF LATEX EXAMINATION GLOVES
K973615 · Macro Rubber Industrial, Inc. · May 1998
CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G
K980754 · Crocker Industrial Resources Sdn. Bhd. · May 1998
SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES
K981348 · Smart Glove Corp. Sdn Bhd · May 1998
HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED
K980848 · P.T. Irama Dinamika Latex · Apr 1998
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
K974424 · Comfort Rubber Gloves Industries Sdn. Bhd. · Apr 1998