Cleared Traditional

K022987 - LAXTEX EXAMINATION GLOVES

K022987 is an FDA 510(k) clearance for LAXTEX 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 42-day FDA review.

K022987 · Arista Latindo Industrial Ltd. P.T · General Hospital
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Oct 2002
Decision
42d
Days
Class 1
Risk

K022987 is an FDA 510(k) clearance for the LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER .... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Arista Latindo Industrial Ltd. P.T (Jakarta, ID). The FDA issued a Cleared decision on October 21, 2002 after a review of 42 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 - K022987

510(k) Number K022987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2002
Decision Date October 21, 2002
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 303
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K022987.
POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORED, WITH PROTEIN LABELING (<50UN/G)
K023577 · Yty Industry (Manjung) Sdn Bhd · Dec 2002
POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES
K023590 · Yty Industry (Manjung) Sdn Bhd · Nov 2002
POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200 MICROGRAM PER GRAM OF GLOVE OR LESS)
K023262 · Perusahaan Getah Asas Sdn. Bhd. · Oct 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS, GREEN COLOR
K022220 · Shen Wei (Usa), Inc. · Sep 2002
POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GEL AND VITAMIN E
K022701 · Perusahaan Getah Asas Sdn. Bhd. · Sep 2002
POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL)
K022601 · Perusahaan Getah Asas Sdn. Bhd. · Aug 2002