Cleared Traditional

K033531 - POWDERED LATEX EXAMINATION GLOVES

K033531 is an FDA 510(k) clearance for POWDERED LATEX EXAMINATION GLOVES, manufactured by Apl International Incorporated Limited. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K033531 · Apl International Incorporated Limited · General Hospital
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Mar 2004
Decision
114d
Days
Class 1
Risk

K033531 is an FDA 510(k) clearance for the POWDERED LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Apl International Incorporated Limited (Dong Nau, VN). The FDA issued a Cleared decision on March 3, 2004 after a review of 114 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.

FDA 510(k) Submission Details - K033531

510(k) Number K033531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2003
Decision Date March 03, 2004
Days to Decision 114 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
15d faster than avg
Panel avg: 129d · This submission: 114d
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 1953
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K033531.
GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM
K040448 · Rosner-Mautby Meditrade(Thailand) , Ltd. · Mar 2004
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)
K040408 · Shun Thai Rubber Gloves Industry Public Co., Ltd. · Mar 2004
MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEMOTHERAPY USE
K033496 · Industrial Clothings, Ltd. · Mar 2004
ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES
K033530 · Asia Pacific Latex Sdn Bhd · Jan 2004
ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
K033532 · Asia Pacific Latex Sdn Bhd · Jan 2004
NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2)
K023537 · Sgmp Co., Ltd. · Nov 2003
K033531 · POWDERED LATEX EXAMINATION GLOVES
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