Cleared Traditional

K973020 - PATIENT EXAMINATION POWDER-FREE GLOVES

K973020 is an FDA 510(k) clearance for PATIENT EXAMINATION POWDER-FREE GLOVES, manufactured by Wear Safe Malaysia Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K973020 · Wear Safe Malaysia Sdn. Bhd. · General Hospital
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Jan 1998
Decision
146d
Days
Class 1
Risk

K973020 is an FDA 510(k) clearance for the PATIENT EXAMINATION POWDER-FREE GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Wear Safe Malaysia Sdn. Bhd. (Port Klang, Selangor, D.E., MY). The FDA issued a Cleared decision on January 6, 1998 after a review of 146 days - within the typical 510(k) review window.

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 Wear Safe Malaysia Sdn. Bhd. devices

FDA 510(k) Submission Details - K973020

510(k) Number K973020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1997
Decision Date January 06, 1998
Days to Decision 146 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
17d slower than avg
Panel avg: 129d · This submission: 146d
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 346
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K973020.
POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)
K980037 · Sri Johani Sdn. Bhd. · Feb 1998
POWDERFREE GREEN LATEX EXAMINATION GLOVES
K980038 · Sri Johani Sdn. Bhd. · Feb 1998
POWDERED GREEN LATEX EXAMINATION GLOVES
K980039 · Sri Johani Sdn. Bhd. · Feb 1998
POWDER FREE HYPROALLERGENIC EXAMINATION GLOVE (WITH LOW PROTEIN CLAIM)
K974065 · Tillotson Healthcare Corp. · Jan 1998
EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE
K974191 · Yty Industry (Manjung) Sdn Bhd · Dec 1997
HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR)
K974184 · Sri Johani Sdn. Bhd. · Dec 1997