Cleared Traditional

K963866 - AMBIDERM (WHITE POW LATEX EXAM GLOVES W/ PROTEIN)

K963866 is an FDA 510(k) clearance for AMBIDERM (WHITE POW LATEX EXAM GLOVES W..., manufactured by Supertex Industrial, S.A. DE C.V.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K963866 · Supertex Industrial, S.A. DE C.V. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 1997
Decision
210d
Days
Class 1
Risk

K963866 is an FDA 510(k) clearance for the AMBIDERM (WHITE POW LATEX EXAM GLOVES W/ PROTEIN). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Supertex Industrial, S.A. DE C.V. (Zapopan, Jalisco, MX). The FDA issued a Cleared decision on February 10, 1997 after a review of 210 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 Supertex Industrial, S.A. DE C.V. devices

FDA 510(k) Submission Details - K963866

510(k) Number K963866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1996
Decision Date February 10, 1997
Days to Decision 210 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
81d slower than avg
Panel avg: 129d · This submission: 210d
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 445
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K963866.
JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING
K964845 · Jinhua Latex Products Factory · Feb 1997
NINGBO YUJIANG LATEX EXAMINATION GLOVES, POWDER-FREE, WITH PROTEIN LABELING
K964847 · Ningbo Yujiang Plastic & Rubber Co. , Ltd. · Feb 1997
OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE
K970297 · Omni Sales Corp. · Feb 1997
DERLIN
K964817 · Derlin Company , Ltd. · Jan 1997
OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE
K964563 · Omni Sales Corp. · Dec 1996
MEDLINE, HYPOALLERGENIC, PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES
K962096 · Medline Industries, Inc. · Nov 1996