Cleared Traditional

K993502 - POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS)

K993502 is an FDA 510(k) clearance for POWDERFREE LATEX EXAMINATION GLOVES (PR..., 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 40-day FDA review.

K993502 · Besglove Medicare Sdn. Bhd. · General Hospital
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Optimized for regulatory review, auditing and printing
Nov 1999
Decision
40d
Days
Class 1
Risk

K993502 is an FDA 510(k) clearance for the POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Besglove Medicare Sdn. Bhd. (Kajang,Selangor Darul,Ehasan, MY). The FDA issued a Cleared decision on November 24, 1999 after a review of 40 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 - K993502

510(k) Number K993502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1999
Decision Date November 24, 1999
Days to Decision 40 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
89d faster than avg
Panel avg: 129d · This submission: 40d
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 810
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K993502.
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS)
K993500 · Besglove Medicare Sdn. Bhd. · Dec 1999
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN LABELING CLAIM 50 MICROGRAM OR LESS
K993820 · Felda Rubber Corp. · Dec 1999
POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS)
K993495 · Besglove Medicare Sdn. Bhd. · Nov 1999
BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS.
K993722 · Hartalega Sdn Bhd · Nov 1999
GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS
K993725 · Hartalega Sdn Bhd · Nov 1999
POWDER FREE GLOVES (POLYMER COATED)
K993183 · Pan-Century Rubber Products Sdn. Bhd. · Nov 1999