Cleared Traditional

K971102 - AMBIDERM

K971102 is an FDA 510(k) clearance for AMBIDERM, 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 156-day FDA review.

K971102 · Supertex Industrial, S.A. DE C.V. · General Hospital
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Aug 1997
Decision
156d
Days
Class 1
Risk

K971102 is an FDA 510(k) clearance for the AMBIDERM. 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 August 29, 1997 after a review of 156 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 - K971102

510(k) Number K971102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1997
Decision Date August 29, 1997
Days to Decision 156 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
27d slower than avg
Panel avg: 129d · This submission: 156d
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 443
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K971102.
ALLIANCE RUBBER, EC-GRIP
K972801 · Alliance Rubber Products Sdn. Bhd. · Oct 1997
POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED)
K973811 · Absolute Quality Leadership, Inc. · Oct 1997
CONFORM NO POWDER (PROTEIN LABELING CLAIM) EXAMINATION GLOVES
K972785 · Ansell Perry · Sep 1997
W.A.
K971200 · W.A. Rubbermate Co., Ltd. · Aug 1997
DASH, SULLIVAN, VITAL GARD
K971044 · Dash Medical Gloves, Inc. · Aug 1997
POWDER FREE LATEX EXAMINATION GLOVES
K970115 · Pt Mbf Buana Multicorpora · Aug 1997