Cleared Traditional

K971360 - SYNTEX

K971360 is an FDA 510(k) clearance for SYNTEX, 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 255-day FDA review.

K971360 · Shinemound Enterprise, Inc. · General Hospital
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Dec 1997
Decision
255d
Days
Class 1
Risk

K971360 is an FDA 510(k) clearance for the SYNTEX. 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 December 22, 1997 after a review of 255 days - an extended review 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: 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 Shinemound Enterprise, Inc. devices

FDA 510(k) Submission Details - K971360

510(k) Number K971360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1997
Decision Date December 22, 1997
Days to Decision 255 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
126d slower than avg
Panel avg: 129d · This submission: 255d
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 139
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K971360.
SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE)
K991951 · Safeskin Corp. · Jul 1999
TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE
K992122 · Maxxim Medical · Jul 1999
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES
K974334 · Hong Huang Tang Industrial Co., Ltd. · Jan 1998
VINYL PATIENT EXAMINATION GLOVES (POWDERED)
K974151 · Shanghai Super Gloves Co., Ltd. · Dec 1997
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K974120 · Shanghai Super Gloves Co., Ltd. · Dec 1997
VINYL PATIENT EXAMINATION GLOVES POWDERED
K973902 · Everrise Glove Products Co., Ltd. · Nov 1997