Cleared Traditional

K982286 - POWDERFREE GREEN LATEX EXAMINATION GLOV...

K982286 is an FDA 510(k) clearance for POWDERFREE GREEN LATEX EXAMINATION GLOV..., manufactured by Besglove Medicare Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K982286 · Besglove Medicare Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
42d
Days
Class 1
Risk

K982286 is an FDA 510(k) clearance for the POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Besglove Medicare Sdn. Bhd. (Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on August 11, 1998 after a review of 42 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 Besglove Medicare Sdn. Bhd. devices

FDA 510(k) Submission Details - K982286

510(k) Number K982286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1998
Decision Date August 11, 1998
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 292
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K982286.
CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K982806 · Perusahaan Getah Asas Sdn. Bhd. · Sep 1998
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K982807 · Perusahaan Getah Asas Sdn. Bhd. · Sep 1998
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K980916 · Perusahaan Getah Asas 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