Cleared Traditional

K011563 - POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM

K011563 is an FDA 510(k) clearance for POWDER FREE LATEX EXAMINATION GLOVES WI..., manufactured by U.O.P. Rubber Products Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K011563 · U.O.P. Rubber Products Sdn Bhd · General Hospital
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Jun 2001
Decision
15d
Days
Class 1
Risk

K011563 is an FDA 510(k) clearance for the POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING .... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by U.O.P. Rubber Products Sdn Bhd (Penang, MY). The FDA issued a Cleared decision on June 5, 2001 after a review of 15 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 U.O.P. Rubber Products Sdn Bhd devices

FDA 510(k) Submission Details - K011563

510(k) Number K011563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2001
Decision Date June 05, 2001
Days to Decision 15 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
114d faster than avg
Panel avg: 129d · This submission: 15d
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 620
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K011563.
NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE WITH STRAW
K011371 · Sgmp Co., Ltd. · Jun 2001
NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5
K011377 · Sgmp Co., Ltd. · Jun 2001
STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TESTED
K010856 · Brightway Holdings Sdn. Bhd. · Jun 2001
EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN LABELING (200
K011376 · Yty Industry (Manjung) Sdn Bhd · May 2001
POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLORED
K011271 · Perusahaan Getah Asas Sdn. Bhd. · May 2001
POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WITH PROTEIN CONTENT LABELING CLAIM (50 MICR0
K010483 · Pt. Medisafe Technologies · May 2001