Cleared Traditional

K013267 - POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICS

K013267 is an FDA 510(k) clearance for POWDER FREE (POLYMER COATED) NON CHLORI..., manufactured by Siam Sempermed Corp., Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K013267 · Siam Sempermed Corp., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
158d
Days
Class 1
Risk

K013267 is an FDA 510(k) clearance for the POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES W.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Siam Sempermed Corp., Ltd. (Palm Harbor, US). The FDA issued a Cleared decision on March 8, 2002 after a review of 158 days - an extended review 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: 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.

View all Siam Sempermed Corp., Ltd. devices

FDA 510(k) Submission Details - K013267

510(k) Number K013267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2001
Decision Date March 08, 2002
Days to Decision 158 days
Submission Type Traditional
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
29d slower than avg
Panel avg: 129d · This submission: 158d
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 402
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K013267.
LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED
K021412 · Arista Latindo Industrial Ltd. P.T · Jun 2002
SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
K021058 · Syntex Healthcare Products Co., Ltd. · May 2002
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
K021059 · Syntex Healthcare Products Co., Ltd. · May 2002
SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) POLYMER COATED WHIT
K014110 · Siam Sempermed Corp., Ltd. · Feb 2002
SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLYMER COATED, NON STERILE, 200 MG OR LESS OF TOTAL WATER E
K014112 · Siam Sempermed Corp., Ltd. · Feb 2002
POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN LABELING CLAIMS
K013793 · Shen Wei (Usa), Inc. · Jan 2002