Cleared Traditional

K942877 - EXAMINATION GLOVES

K942877 is an FDA 510(k) clearance for EXAMINATION GLOVES, manufactured by Masif Healthcare Products Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K942877 · Masif Healthcare Products Sdn. Bhd. · General Hospital
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Oct 1994
Decision
112d
Days
Class 1
Risk

K942877 is an FDA 510(k) clearance for the EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Masif Healthcare Products Sdn. Bhd. (Ipoh, Perak, Darul Ridzuan, MY). The FDA issued a Cleared decision on October 7, 1994 after a review of 112 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 Masif Healthcare Products Sdn. Bhd. devices

FDA 510(k) Submission Details - K942877

510(k) Number K942877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1994
Decision Date October 07, 1994
Days to Decision 112 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 faster than avg
Panel avg: 129d · This submission: 112d
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 294
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K942877.
COMFIT
K944140 · Wembley Rubber Products (M) Sdn Bhd · Dec 1994
COMFIT EXAMINATION GLOVES, POWDER FREE, HYPOALLERGENIC
K942947 · Wembley Rubber Products (M) Sdn Bhd · Nov 1994
COMFIT (STERILE)
K944141 · Wembley Rubber Products (M) Sdn Bhd · Oct 1994
MICRO-TOUCH LATEX MEDICAL GLOVES
K943620 · Johnson & Johnson Medical, Inc. · Sep 1994
SCIPOTEX POWDER FREE EXAM GLOVES (UNBEADED)
K942510 · Wembley Rubber Products (M) Sdn Bhd · Aug 1994
COMFIT GREEN POWDERED EXAMINATION GLOVES
K936265 · Wembley Rubber Products (M) Sdn Bhd · Jun 1994