Cleared Traditional

K924233 - SAVACARE LATEX EXAMINATION GLOVES

K924233 is an FDA 510(k) clearance for SAVACARE LATEX EXAMINATION GLOVES, manufactured by Preventive Care, Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K924233 · Preventive Care, Inc. · General Hospital
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Mar 1993
Decision
200d
Days
Class 1
Risk

K924233 is an FDA 510(k) clearance for the SAVACARE LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Preventive Care, Inc. (Eagan, US). The FDA issued a Cleared decision on March 12, 1993 after a review of 200 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.

FDA 510(k) Submission Details - K924233

510(k) Number K924233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1992
Decision Date March 12, 1993
Days to Decision 200 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
71d slower than avg
Panel avg: 129d · This submission: 200d
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 1953
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K924233.
DENTA SAFE LATEX EXAMINATION GLOVES
K915514 · Dental Care Intl., Inc. · May 1993
DERMATOUCH PLUS HYPOALLERGENIC EXAMINATION GLOVES
K925358 · Colonial Surgical Supply, Inc. · Apr 1993
DOCTOR'S CHOICE LATEX EXAMINATION GLOVES
K924265 · Chesire Laboratories · Mar 1993
ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES
K913766 · Ansell, Inc. · Mar 1993
PATIENT EXAMINATION GLOVES
K915607 · Seal Polymer Industries Bhd. · Mar 1993
STERLING LATEX EXAM GLOVE, HYPO-ALLERGENIC
K924959 · Perlink USA, Inc. · Mar 1993
K924233 · SAVACARE LATEX EXAMINATION GLOVES
Download PDF Preventive Care, Inc.