Cleared Traditional

K963331 - MEDTEXX

K963331 is an FDA 510(k) clearance for MEDTEXX, manufactured by Regalfield Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K963331 · Regalfield Sdn. Bhd. · General Hospital
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Jan 1997
Decision
154d
Days
Class 1
Risk

K963331 is an FDA 510(k) clearance for the MEDTEXX. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Regalfield Sdn. Bhd. (Taiping, Perak, MY). The FDA issued a Cleared decision on January 24, 1997 after a review of 154 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 Regalfield Sdn. Bhd. devices

FDA 510(k) Submission Details - K963331

510(k) Number K963331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1996
Decision Date January 24, 1997
Days to Decision 154 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
25d slower than avg
Panel avg: 129d · This submission: 154d
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 678
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K963331.
OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE
K970297 · Omni Sales Corp. · Feb 1997
AMBIDERM (WHITE POW LATEX EXAM GLOVES W/ PROTEIN)
K963866 · Supertex Industrial, S.A. DE C.V. · Feb 1997
AMBIDERM (COLOR POW LATEX EXAM GLOVES W/ PROTEIN)
K962737 · Supertex Industrial, S.A. DE C.V. · Feb 1997
FOXELL, MEDIGUARD, PLUS MULTIPLE BRAND NAMES
K964317 · Nantong Ruchang Latex Products Co., Ltd. · Jan 1997
DERLIN
K964817 · Derlin Company , Ltd. · Jan 1997
DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM
K955425 · Dash Medical Gloves Sdn Bhd · Dec 1996