Cleared Abbreviated

K051329 - STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 UG OR LESS)

K051329 is an FDA 510(k) clearance for STERILE POWDER-FREE LATEX EXAMINATION G..., manufactured by Siam Sempermed Corp., Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Abbreviated 510(k) pathway after a 60-day FDA review.

K051329 · Siam Sempermed Corp., Ltd. · General Hospital
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Jul 2005
Decision
60d
Days
Class 1
Risk

K051329 is an FDA 510(k) clearance for the STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Siam Sempermed Corp., Ltd. (Clearwater, US). The FDA issued a Cleared decision on July 19, 2005 after a review of 60 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Siam Sempermed Corp., Ltd. devices

FDA 510(k) Submission Details - K051329

510(k) Number K051329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2005
Decision Date July 19, 2005
Days to Decision 60 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 129d · This submission: 60d
Pathway characteristics
Standards-based clearance path.

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 402
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K051329.
POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF
K060775 · Kossan Latex Industries(M)Sdn Bhd · May 2006
BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR)
K060658 · Brightway Holdings Sdn. Bhd. · Apr 2006
NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING
K052016 · Sgmp Co., Ltd. · Sep 2005
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW)
K050277 · Hartalega Sdn Bhd · Jun 2005
DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT
K032016 · Wrp Specialty Products Sdn. Bhd. · May 2004
DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI
K040645 · Wrp Asia Pacific Sdn. Bhd. · Apr 2004