Cleared Traditional

K943552 - POWDER-FREE GLOVES

K943552 is an FDA 510(k) clearance for POWDER-FREE GLOVES, manufactured by Healthcare Gloves Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K943552 · Healthcare Gloves Sdn Bhd · General Hospital
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Dec 1994
Decision
140d
Days
Class 1
Risk

K943552 is an FDA 510(k) clearance for the POWDER-FREE GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Healthcare Gloves Sdn Bhd (Batu Caves Selangor, MY). The FDA issued a Cleared decision on December 8, 1994 after a review of 140 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 Healthcare Gloves Sdn Bhd devices

FDA 510(k) Submission Details - K943552

510(k) Number K943552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1994
Decision Date December 08, 1994
Days to Decision 140 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
11d slower than avg
Panel avg: 129d · This submission: 140d
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 304
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K943552.
SCIPOTEX
K943868 · Wembley Rubber Products (M) Sdn Bhd · Feb 1995
POWDERFREE LATEX EXAMINATION GLOVE
K945247 · Sri Johani Sdn. Bhd. · Jan 1995
LATEX MEDICAL GLOVE
K943900 · Johnson & Johnson Medical, Inc. · Dec 1994
COMFIT BLUE POWDERED EXAMINATION GLOVES
K936268 · Wembley Rubber Products (M) Sdn Bhd · Dec 1994
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