Cleared Traditional

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

K991686 is an FDA 510(k) clearance for 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 25-day FDA review.

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

FDA 510(k) Submission Details - K991686

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 129d · This submission: 25d
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 836
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K991686.
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES
K991155 · C.V. Anlis Abadi International · Jun 1999
HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVES
K991305 · M.R.G. Industries Sdn. Bhd. · Jun 1999
NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN CLAIM OF 50 MICROGRAM O
K991742 · Yty Industry (Manjung) Sdn Bhd · Jun 1999
SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE
K990488 · Terang Nusa Sdn Bhd · May 1999
LATEX EXAMINATION GLOVES- POWDER FREE, SIZES EXTRA SMALL, SMALL,MEDIUM,LARGE,EXTRA LARGE
K991158 · P. T. Tata Rubberindo Industries · May 1999
QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED
K991462 · Latexx Partners Bhd. · May 1999