Cleared Traditional

K013320 - BLUE LATEX EXAMINATION GLOVES, POWDER FREE

K013320 is an FDA 510(k) clearance for BLUE LATEX EXAMINATION GLOVES, manufactured by Arista Latindo Industrial Ltd. P.T. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K013320 · Arista Latindo Industrial Ltd. P.T · General Hospital
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Dec 2001
Decision
75d
Days
Class 1
Risk

K013320 is an FDA 510(k) clearance for the BLUE LATEX EXAMINATION GLOVES, POWDER FREE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Arista Latindo Industrial Ltd. P.T (Jakarta Barat, ID). The FDA issued a Cleared decision on December 19, 2001 after a review of 75 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 Arista Latindo Industrial Ltd. P.T devices

FDA 510(k) Submission Details - K013320

510(k) Number K013320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2001
Decision Date December 19, 2001
Days to Decision 75 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
54d faster than avg
Panel avg: 129d · This submission: 75d
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 834
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K013320.
POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K013554 · Maxter Glove Manufacturing Sdn Bhd · Jan 2002
CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA
K013589 · Supermax Glove Manufacturing Sdn Bhd · Jan 2002
POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING)
K013942 · Wrp Specialty Products Sdn. Bhd. · Dec 2001
TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K013317 · Tekmedic (M) Sdn Bhd · Dec 2001
LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL CLAIM
K013333 · Innovative Gloves Co;, Ltd. · Dec 2001
ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
K013537 · Koon Seng Sdn Bhd · Dec 2001