Cleared Traditional

K001557 - LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)

K001557 is an FDA 510(k) clearance for LAXTEX POWDERED EXAMINATION GLOVE WITH ..., manufactured by Kossan Latex Industries(M)Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K001557 · Kossan Latex Industries(M)Sdn Bhd · General Hospital
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Jun 2000
Decision
21d
Days
Class 1
Risk

K001557 is an FDA 510(k) clearance for the LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Kossan Latex Industries(M)Sdn Bhd (Klang, Selangor, MY). The FDA issued a Cleared decision on June 9, 2000 after a review of 21 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 Kossan Latex Industries(M)Sdn Bhd devices

FDA 510(k) Submission Details - K001557

510(k) Number K001557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2000
Decision Date June 09, 2000
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
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 629
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K001557.
POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
K001674 · Pamitex Industries Sdn Bhd · Jun 2000
POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES
K001672 · Pamitex Industries Sdn Bhd · Jun 2000
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA
K001529 · Perusahaan Getah Asas Sdn. Bhd. · Jun 2000
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE
K001190 · Kossan Latex Industries(M)Sdn Bhd · May 2000
GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING)
K994426 · Pt. Wrp Buana Multicorpora · May 2000
COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES
K001280 · Wrp Asia Pacific Sdn. Bhd. · May 2000