Cleared Traditional

K974371 - CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE

K974371 is an FDA 510(k) clearance for CLK INT'L POWDER FREE LATEX EXAMINATION..., manufactured by Clk Intl., Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K974371 · Clk Intl., Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
152d
Days
Class 1
Risk

K974371 is an FDA 510(k) clearance for the CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Clk Intl., Inc. (New York, US). The FDA issued a Cleared decision on April 21, 1998 after a review of 152 days - an extended review 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: 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.

FDA 510(k) Submission Details - K974371

510(k) Number K974371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1997
Decision Date April 21, 1998
Days to Decision 152 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 129d · This submission: 152d
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 1329
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K974371.
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
POWDER FREE CHLORINATED GLOVES-(TEXTURED)
K981164 · Pan-Century Rubber Products Sdn. Bhd. · 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
SAFETY POWDERED BLUE LATEX EXAMINATION GLOVES
K980939 · Besglove Medicare Sdn. Bhd. · Apr 1998
K974371 · CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE
Download PDF FDA Summary Clk Intl., Inc.