Cleared Traditional

K951007 - MORE CHAIN POWDER FREE VINYL EXAMINATION GLOVES

K951007 is an FDA 510(k) clearance for MORE CHAIN POWDER FREE VINYL EXAMINATIO..., manufactured by Allerderm Laboratories, Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K951007 · Allerderm Laboratories, Inc. · General Hospital
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Jul 1995
Decision
148d
Days
Class 1
Risk

K951007 is an FDA 510(k) clearance for the MORE CHAIN POWDER FREE VINYL EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Allerderm Laboratories, Inc. (Mill Valley, US). The FDA issued a Cleared decision on July 26, 1995 after a review of 148 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 Allerderm Laboratories, Inc. devices

FDA 510(k) Submission Details - K951007

510(k) Number K951007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1995
Decision Date July 26, 1995
Days to Decision 148 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
19d slower than avg
Panel avg: 129d · This submission: 148d
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 K951007.
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