Cleared Traditional

K010347 - LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE

K010347 is an FDA 510(k) clearance for LATEX EXAMINATION GLOVES-POWDERED, manufactured by Enzymic Technologies Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K010347 · Enzymic Technologies Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
50d
Days
Class 1
Risk

K010347 is an FDA 510(k) clearance for the LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Enzymic Technologies Sdn Bhd (Melaka, MY). The FDA issued a Cleared decision on March 27, 2001 after a review of 50 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 Enzymic Technologies Sdn Bhd devices

FDA 510(k) Submission Details - K010347

510(k) Number K010347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2001
Decision Date March 27, 2001
Days to Decision 50 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 129d · This submission: 50d
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 620
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K010347.
POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WITH PROTEIN CONTENT LABELING CLAIM (50 MICR0
K010483 · Pt. Medisafe Technologies · May 2001
ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB
K002718 · Tillotson Healthcare Corp. · May 2001
HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE)
K003350 · Pamitex Industries Sdn Bhd · Apr 2001
NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH & WITHOUT GRAPE SCENT WITH PROTEIN LABELING (200 MICROGRAMS OR
K010095 · Sgmp Co., Ltd. · Feb 2001
SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K004048 · Tillotson Healthcare Corp. · Feb 2001
POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS)
K003737 · Perusahaan Getah Asas Sdn. Bhd. · Feb 2001