Cleared Traditional

K930266 - VINYL EXAMINATION GLOVES

K930266 is an FDA 510(k) clearance for VINYL EXAMINATION GLOVES, manufactured by Shanghai PM Plastics Enterise Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K930266 · Shanghai PM Plastics Enterise Co., Ltd. · General Hospital
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Nov 1993
Decision
307d
Days
Class 1
Risk

K930266 is an FDA 510(k) clearance for the VINYL EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai PM Plastics Enterise Co., Ltd. (Songjiang Co., Shanghai, CN). The FDA issued a Cleared decision on November 22, 1993 after a review of 307 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K930266

510(k) Number K930266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1993
Decision Date November 22, 1993
Days to Decision 307 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
178d slower than avg
Panel avg: 129d · This submission: 307d
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 798
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K930266.
VINYL EXAMINATION GLOVES (NON STERILE)
K934536 · Arista Latindo Industrial Ltd. P.T · Jun 1994
KIT,I.V. START
K940035 · Mason-Keller Corp. · Jun 1994
VINYL EXAMINATION GLOVE, POWDER FREE
K941357 · Canopus Medical Supply Co., Ltd. · Apr 1994
SENSICARE POWDER FREE MEDICAL GLOVE
K925244 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1993
VINYL EXAM GLOVES
K922968 · Normandin Pacific Holdings Corp. · Jan 1993
DERMACARE SYNTHETIC MEDICAL GLOVE
K914763 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
K930266 · VINYL EXAMINATION GLOVES
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