Cleared Traditional

K971415 - VINYL PATIENT EXAMINATION GLOVE, POWDER-FREE

K971415 is an FDA 510(k) clearance for VINYL PATIENT EXAMINATION GLOVE, manufactured by Shanghai Foremost Plastic Industrial Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K971415 · Shanghai Foremost Plastic Industrial Co., Ltd. · General Hospital
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May 1997
Decision
36d
Days
Class 1
Risk

K971415 is an FDA 510(k) clearance for the VINYL PATIENT EXAMINATION GLOVE, POWDER-FREE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai Foremost Plastic Industrial Co., Ltd. (Songjiang County, Shanghai, CN). The FDA issued a Cleared decision on May 23, 1997 after a review of 36 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shanghai Foremost Plastic Industrial Co., Ltd. devices

FDA 510(k) Submission Details - K971415

510(k) Number K971415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1997
Decision Date May 23, 1997
Days to Decision 36 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 129d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 138
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K971415.
POLY (VINYL) EXAM GLOVE, POWDER-FREE
K972624 · Copioumed Intl., Inc. · Nov 1997
POLY (VINYL) EXAM GLOVE, POWDERED
K971316 · Copioumed Intl., Inc. · Aug 1997
LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES
K972104 · Shinemound Enterprise, Inc. · Aug 1997
VINYL PATIENT EXAMINATION GLOVE, POWDERED
K971423 · Shanghai Foremost Plastic Industrial Co., Ltd. · May 1997
VINYL EXAM GLOVE POWERED
K970144 · Hiyi Export Co. · Apr 1997
JIAWANG POWDER-FREE VINYL EXAMINATION GLOVES
K970111 · Shanghai Jiawang Industrial Co. , Ltd. · Mar 1997