Cleared Traditional

K980803 - STERILE POWDER-FREE LATEX EXAMINATION GLOVES

K980803 is an FDA 510(k) clearance for STERILE POWDER-FREE LATEX EXAMINATION G..., manufactured by Kenwell International , Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K980803 · Kenwell International , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
32d
Days
Class 1
Risk

K980803 is an FDA 510(k) clearance for the STERILE POWDER-FREE LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Kenwell International , Ltd. (Great Neck,, US). The FDA issued a Cleared decision on April 3, 1998 after a review of 32 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 Kenwell International , Ltd. devices

FDA 510(k) Submission Details - K980803

510(k) Number K980803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1998
Decision Date April 03, 1998
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
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 K980803.
POWDER FREE CHLORINATED GLOVES-(TEXTURED)
K981164 · Pan-Century Rubber Products 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
SAFETY POWDERED BLUE LATEX EXAMINATION GLOVES
K980939 · Besglove Medicare Sdn. Bhd. · Apr 1998
SAFETY POWDERFREE BLUE LATEX EXAMINTION GLOVES
K980940 · Besglove Medicare Sdn. Bhd. · Apr 1998
SAFETY POWDERFREE BLUE LATEX EXAMINATION GLOVES (POLYMER COATED)
K980941 · Besglove Medicare Sdn. Bhd. · Apr 1998