Cleared Traditional

K972104 - LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES

K972104 is an FDA 510(k) clearance for LIGHTLY POWDERED VINYL SYNTHETIC EXAMIN..., manufactured by Shinemound Enterprise, Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K972104 · Shinemound Enterprise, Inc. · General Hospital
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Aug 1997
Decision
72d
Days
Class 1
Risk

K972104 is an FDA 510(k) clearance for the LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shinemound Enterprise, Inc. (Billerica, US). The FDA issued a Cleared decision on August 15, 1997 after a review of 72 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 Shinemound Enterprise, Inc. devices

FDA 510(k) Submission Details - K972104

510(k) Number K972104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1997
Decision Date August 15, 1997
Days to Decision 72 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
57d faster than avg
Panel avg: 129d · This submission: 72d
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 138
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K972104.
VINYL PATIENT EXAMINATION GLOVES POWDER-FREE
K973998 · Everrise Glove Products Co., Ltd. · Nov 1997
POLY (VINYL) EXAM GLOVE, POWDER-FREE
K972624 · Copioumed Intl., Inc. · Nov 1997
POLY (VINYL) EXAM GLOVE, POWDERED
K971316 · Copioumed Intl., Inc. · Aug 1997
VINYL PATIENT EXAMINATION GLOVE, POWDER-FREE
K971415 · Shanghai Foremost Plastic Industrial Co., Ltd. · May 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