Cleared Traditional

K020042 - HYCARE LATEX EXAMINATION GLOVE, POWDER FREE

K020042 is an FDA 510(k) clearance for HYCARE LATEX EXAMINATION GLOVE, manufactured by Hycare Intl. Co., Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K020042 · Hycare Intl. Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
204d
Days
Class 1
Risk

K020042 is an FDA 510(k) clearance for the HYCARE LATEX EXAMINATION GLOVE, POWDER FREE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Hycare Intl. Co., Ltd. (Sparks, US). The FDA issued a Cleared decision on July 30, 2002 after a review of 204 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Hycare Intl. Co., Ltd. devices

FDA 510(k) Submission Details - K020042

510(k) Number K020042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2002
Decision Date July 30, 2002
Days to Decision 204 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 129d · This submission: 204d
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 616
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K020042.
SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE
K022146 · Syntex Healthcare Products Co., Ltd. · Sep 2002
POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL)
K022601 · Perusahaan Getah Asas Sdn. Bhd. · Aug 2002
TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)
K021855 · Top Glove Sdn. Bhd. · Aug 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS
K020818 · Allegiance Healthcare Corp. · Jul 2002
ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE MADE FROM ALLOTEX AN ENZYME TREATED NATURAL
K021007 · Tillotson Healthcare Corp. · Jul 2002
STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN 50U/G OF GLOVES
K021521 · Smart Glove Corp. Sdn Bhd · Jul 2002