Cleared Traditional

K941809 - VINYL PATIENT EXAMINATION GLOVES

K941809 is an FDA 510(k) clearance for VINYL PATIENT EXAMINATION GLOVES, manufactured by Cheer & Merit Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 464-day FDA review.

K941809 · Cheer & Merit Co., Ltd. · General Hospital
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Jul 1995
Decision
464d
Days
Class 1
Risk

K941809 is an FDA 510(k) clearance for the VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Cheer & Merit Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on July 20, 1995 after a review of 464 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Cheer & Merit Co., Ltd. devices

FDA 510(k) Submission Details - K941809

510(k) Number K941809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1994
Decision Date July 20, 1995
Days to Decision 464 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
335d slower than avg
Panel avg: 129d · This submission: 464d
Pathway characteristics
Predicate-based equivalence.

LYZ Device Classification - Class 1, General Controls

Product Code LYZ Vinyl Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) 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 - LYZ Vinyl Patient Examination Glove

All 595
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K941809.
GLOVE, EXAMINATION, VINYL
K952050 · Oak Carolina, Inc. · Aug 1996
SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES
K960746 · Sunmax Enterprise Shanghai Co. , Ltd. · Jun 1996
ARISTA VINYL EXAMINATION GLOVES
K954153 · Arista Latindo Industrial Ltd. P.T · Jan 1996
TRIFLEX STERILE SYNTHETIC EXAMINATION GLOVES
K952786 · Baxter Healthcare Corp · Jul 1995
TRIFLEX NON-STERILE SYNTHITIC EXAMINATION GLOVES
K944873 · Baxter Healthcare Corp · Mar 1995
TRU-TOUCH MEDICAL GLOVES
K944183 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1995