Cleared Traditional

K010078 - GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE)

K010078 is an FDA 510(k) clearance for GUTHRIE SHIELD PLUS BLUE LATEX EXAMINAT..., manufactured by Guthrie Medicare Products (Melaka) Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K010078 · Guthrie Medicare Products (Melaka) Sdn Bhd · General Hospital
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Jan 2001
Decision
19d
Days
Class 1
Risk

K010078 is an FDA 510(k) clearance for the GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Guthrie Medicare Products (Melaka) Sdn Bhd (Great Neck, US). The FDA issued a Cleared decision on January 29, 2001 after a review of 19 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Guthrie Medicare Products (Melaka) Sdn Bhd devices

FDA 510(k) Submission Details - K010078

510(k) Number K010078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2001
Decision Date January 29, 2001
Days to Decision 19 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 129d · This submission: 19d
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 583
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K010078.
NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH & WITHOUT GRAPE SCENT WITH PROTEIN LABELING (200 MICROGRAMS OR
K010095 · Sgmp Co., Ltd. · Feb 2001
SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K004048 · Tillotson Healthcare Corp. · Feb 2001
POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS)
K003737 · Perusahaan Getah Asas Sdn. Bhd. · Feb 2001
FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM A
K002719 · Tillotson Healthcare Corp. · Jan 2001
MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K003055 · Medline Industries, Inc. · Jan 2001
STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
K003653 · Wrp Asia Pacific Sdn. Bhd. · Jan 2001