Cleared Traditional

K890115 - AMBI-DEX (LATEX EXAMINATION GLOVES)

K890115 is an FDA 510(k) clearance for AMBI-DEX (LATEX EXAMINATION GLOVES), manufactured by Globe Safety Products, Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K890115 · Globe Safety Products, Inc. · General Hospital
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Sep 1989
Decision
233d
Days
Class 1
Risk

K890115 is an FDA 510(k) clearance for the AMBI-DEX (LATEX EXAMINATION GLOVES). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Globe Safety Products, Inc. (N.T. Hong Kong, GB). The FDA issued a Cleared decision on September 1, 1989 after a review of 233 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 Globe Safety Products, Inc. devices

FDA 510(k) Submission Details - K890115

510(k) Number K890115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1989
Decision Date September 01, 1989
Days to Decision 233 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 129d · This submission: 233d
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 726
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K890115.
STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC'
K895807 · Safeskin Corp. · Dec 1989
STRAWBERRY SCENTED LATEX EXAMINATION GLOVES
K896135 · Arista Latindo Industrial Ltd. P.T · Dec 1989
LATEX EXAMINATION GLOVES (POWDER-FREE/HYPO-ALLER.)
K894497 · Safeskin Corp. · Nov 1989
PATIENT EXAMINATION GLOVES (LATEX)
K894022 · Baxter Healthcare Corp · Aug 1989
MODIFIED PATIENT EXAMINATION GLOVES
K894311 · Safeskin Corp. · Aug 1989
B-D PATIENT EXAMINATION GLOVES
K894280 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989