Cleared Traditional

K981164 - POWDER FREE CHLORINATED GLOVES-(TEXTURED)

K981164 is an FDA 510(k) clearance for POWDER FREE CHLORINATED GLOVES-(TEXTURED), manufactured by Pan-Century Rubber Products Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K981164 · Pan-Century Rubber Products Sdn. Bhd. · General Hospital
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Apr 1998
Decision
23d
Days
Class 1
Risk

K981164 is an FDA 510(k) clearance for the POWDER FREE CHLORINATED GLOVES-(TEXTURED). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pan-Century Rubber Products Sdn. Bhd. (Pasir Gudang, Johor, MY). The FDA issued a Cleared decision on April 23, 1998 after a review of 23 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 Pan-Century Rubber Products Sdn. Bhd. devices

FDA 510(k) Submission Details - K981164

510(k) Number K981164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1998
Decision Date April 23, 1998
Days to Decision 23 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
106d faster than avg
Panel avg: 129d · This submission: 23d
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 582
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K981164.
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
CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE
K974371 · Clk Intl., Inc. · Apr 1998
LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE)
K980605 · Pt. Sarana Indoprotex · Apr 1998
STERILE POWDER-FREE LATEX EXAMINATION GLOVES
K980803 · Kenwell International , Ltd. · Apr 1998