Cleared Traditional

LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS) (K991686) - FDA 510(k) Clearance

Class I General Hospital device.

K991686 · Arista Latindo Industrial Ltd. P.T · General Hospital
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Jun 1999
Decision
25d
Days
Class 1
Risk

K991686 is an FDA 510(k) clearance for the LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR .... 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 June 11, 1999 after a review of 25 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

Submission Details

510(k) Number K991686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1999
Decision Date June 11, 1999
Days to Decision 25 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
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 42
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K991686.
SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)
K171367 · Sanrea Healthcare Products Pvt, Ltd. · Jan 2018
EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM
K103602 · Medline Industries, Inc. · Apr 2011
MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K003055 · Medline Industries, Inc. · Jan 2001
MEDLINE, HYPOALLERGENIC, PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES
K962096 · Medline Industries, Inc. · Nov 1996
MEDLINE PWDER-FREE VIBNYL EXAMIUNATION GLOVES/VINYL GLOVES, STERILE (MDS 192074,5,6)
K962076 · Medline Industries, Inc. · Aug 1996
MEDLINE PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES
K962094 · Medline Industries, Inc. · Aug 1996