Cleared Traditional

K954293 - PATIENT EXAMINATION GLOVE (POWDERED)

K954293 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVE (POWDERED), manufactured by Medline Products Co. , Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K954293 · Medline Products Co. , Ltd. · General Hospital
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Jul 1996
Decision
316d
Days
Class 1
Risk

K954293 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVE (POWDERED). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Medline Products Co. , Ltd. (Songkhla, TH). The FDA issued a Cleared decision on July 26, 1996 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medline Products Co. , Ltd. devices

FDA 510(k) Submission Details - K954293

510(k) Number K954293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1995
Decision Date July 26, 1996
Days to Decision 316 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
187d slower than avg
Panel avg: 129d · This submission: 316d
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 582
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K954293.
PATIENT LATEX EXAMINATION GLOVES (POWDERED, NON STERILE)
K962650 · Sti Medical Sdn Bhd · Aug 1996
POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) PATIENT EXAMINATION GLOVES
K960225 · Tillotson Healthcare Corp. · Jul 1996
ULTRA CARE POWDER FREE HYPOALLERGENIC PATIENT EXAMINATION GLOVE
K960247 · Tillotson Healthcare Corp. · Jul 1996
COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
K962188 · Wembley Rubber Products (M) Sdn Bhd · Jul 1996
COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
K962189 · Wembley Rubber Products (M) Sdn Bhd · Jul 1996
BG PATIENT EXAMINATION GLOVES, NON-STERILE
K961675 · Biografik (Malaysia) Sdn Bhd · Jul 1996