Cleared Traditional

PATIENT EXAMINATION GLOVES (LATEX) (K892750) - FDA 510(k) Clearance

Class I General Hospital device.

K892750 · Baxter Healthcare Corp · General Hospital
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Jul 1989
Decision
94d
Days
Class 1
Risk

K892750 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVES (LATEX). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on July 14, 1989 after a review of 94 days - within the typical 510(k) review window.

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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K892750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1989
Decision Date July 14, 1989
Days to Decision 94 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 129d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 41
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K892750.
B-D PATIENT EXAMINATION GLOVES
K894280 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989
ACCU-TOUCH LATEX EXAM GLOVES, UNISIZE & LARGE
K891791 · Medline Industries, Inc. · Jul 1989
MEDLINE LATEX EXAM GLOVES
K892075 · Medline Industries, Inc. · Jul 1989
PATIENT EXAMINATION GLOVES (DENTAL)
K892751 · Baxter Healthcare Corp · Jul 1989