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.

View all Siam Sempermed Corp., Ltd. devices

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 402
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K946257.
CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE
K952367 · Cypress Medical Products, Ltd. · Jul 1995
SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE
K952556 · Aladan Corp. · Jun 1995
ALADAN HYPOALLERGENIC LATEX MEDICAL EXAMINATION GLOVES
K951839 · Aladan Corp. · Jun 1995
COMFIT (PINK)
K943601 · Wembley Rubber Products (M) Sdn Bhd · May 1995
COMFIT/GREEN POWDERED EXAMINATION GLOVES
K951667 · Wembley Rubber Products (M) Sdn Bhd · May 1995
SCIPOTEX/POWDER FREE EXAMINATION GLOVES
K951668 · Wembley Rubber Products (M) Sdn Bhd · May 1995