Cleared Traditional

K946257 - LATEX PATIENT EXAMINATION GLOVE POWDER FREE (HYPOALLERGENIC)

K946257 is an FDA 510(k) clearance for LATEX PATIENT EXAMINATION GLOVE POWDER ..., 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 167-day FDA review.

K946257 · Siam Sempermed Corp., Ltd. · General Hospital
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Jun 1995
Decision
167d
Days
Class 1
Risk

K946257 is an FDA 510(k) clearance for the LATEX PATIENT EXAMINATION GLOVE POWDER FREE (HYPOALLERGENIC). 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 June 8, 1995 after a review of 167 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.

FDA 510(k) Submission Details - K946257

510(k) Number K946257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1994
Decision Date June 08, 1995
Days to Decision 167 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
38d slower than avg
Panel avg: 129d · This submission: 167d
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 1234
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K946257.
DISPOSABLE LATEX PATIENT EXAMINATION GLOVES
K951670 · Emi Groups (U.S.A.), Inc. · Jun 1995
ALADAN HYPOALLERGENIC LATEX MEDICAL EXAMINATION GLOVES
K951839 · Aladan Corp. · Jun 1995
WOUND CARE MANAGEMENT KITS
K952335 · Continental Medical Laboratories, Inc. · Jun 1995
POWDER FREE LATEX EXAMINATION GLOVES
K950450 · Rampart Glove Co. · Jun 1995
MEGA MEDITEX LIMITED
K950622 · Mega Meditex , Ltd. · Jun 1995
JAI
K951513 · Intl. Trade Management Co. · May 1995
K946257 · LATEX PATIENT EXAMINATION GLOVE POWDER FREE (HYPOALLERGENIC)
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