Cleared Traditional

K935033 - MULTI-COMFORT POWDER FREE

K935033 is an FDA 510(k) clearance for MULTI-COMFORT POWDER FREE, manufactured by Perusahaan Intan Emas Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K935033 · Perusahaan Intan Emas Sdn. Bhd. · General Hospital
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Feb 1994
Decision
105d
Days
Class 1
Risk

K935033 is an FDA 510(k) clearance for the MULTI-COMFORT POWDER FREE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Perusahaan Intan Emas Sdn. Bhd. (56100 Kuala Lumpur, Malaysia, MY). The FDA issued a Cleared decision on February 2, 1994 after a review of 105 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.

FDA 510(k) Submission Details - K935033

510(k) Number K935033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1993
Decision Date February 02, 1994
Days to Decision 105 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
24d faster than avg
Panel avg: 129d · This submission: 105d
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 1363
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K935033.
MEDIGLOVES, FISHERBRAND, MEDIPRODUCTS GLOVES
K930795 · Medigloves , Ltd. · Feb 1994
COLORED POWDER FREE PATIENT EXAMINATION GLOVES
K935699 · Glove India Private , Ltd. · Feb 1994
PARTNERS LATEX EXAM GLOVES PLUS MULTIPLE NAMES
K934408 · Sjs Supreme, Inc. · Feb 1994
COMFIT
K933263 · Wembley Rubber Products (M) Sdn Bhd · Feb 1994
ULTRA SHIELD PF
K934171 · Medical Resources International, Inc. · Feb 1994
PHYNE-TOUCH PF
K931250 · Medical Resources, Ltd. · Jan 1994
K935033 · MULTI-COMFORT POWDER FREE
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