Cleared Traditional

K010803 - POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR

K010803 is an FDA 510(k) clearance for POWDER-FREE LATEX EXAMINATION GLOVES-BL..., manufactured by Hwa Teh Industrial Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K010803 · Hwa Teh Industrial Sdn. Bhd. · General Hospital
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May 2001
Decision
56d
Days
Class 1
Risk

K010803 is an FDA 510(k) clearance for the POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Hwa Teh Industrial Sdn. Bhd. (Batang Berjuntai, MY). The FDA issued a Cleared decision on May 11, 2001 after a review of 56 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.

FDA 510(k) Submission Details - K010803

510(k) Number K010803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2001
Decision Date May 11, 2001
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
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 1363
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K010803.
EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN LABELING (200
K011376 · Yty Industry (Manjung) Sdn Bhd · May 2001
UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K010881 · N.S. Uni-Gloves Sdn. Bhd. · May 2001
SKINGARD POLYCOAT GLOVE
K004018 · Top Quality Mfg., Inc. · May 2001
UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K010879 · N.S. Uni-Gloves 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
K010803 · POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
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