Cleared Traditional

K946111 - PROSHIELD PLUS MULTIPLE

K946111 is an FDA 510(k) clearance for PROSHIELD PLUS MULTIPLE, manufactured by Sino (U.S.A.) Co.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K946111 · Sino (U.S.A.) Co. · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 1995
Decision
131d
Days
Class 1
Risk

K946111 is an FDA 510(k) clearance for the PROSHIELD PLUS MULTIPLE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Sino (U.S.A.) Co. (Rowland Heights, US). The FDA issued a Cleared decision on April 25, 1995 after a review of 131 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.

View all Sino (U.S.A.) Co. devices

FDA 510(k) Submission Details - K946111

510(k) Number K946111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1994
Decision Date April 25, 1995
Days to Decision 131 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 129d · This submission: 131d
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 709
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K946111.
SCIPOTEX (BLUE)
K951456 · Wembley Rubber Products (M) Sdn Bhd · Apr 1995
ULTIMAX
K951467 · Wembley Rubber Products (M) Sdn Bhd · Apr 1995
COMFIT
K951468 · Wembley Rubber Products (M) Sdn Bhd · Apr 1995
COMFIT PINK POWDERED EXAMINATION GLOVES (HYPOALLERGENIC)
K936266 · Wembley Rubber Products (M) Sdn Bhd · Apr 1995
COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC)
K951137 · Wembley Rubber Products (M) Sdn Bhd · Apr 1995
SCIPOTEX
K951171 · Wembley Rubber Products (M) Sdn Bhd · Apr 1995