Cleared Traditional

K974120 - POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

K974120 is an FDA 510(k) clearance for POWDER-FREE VINYL PATIENT EXAMINATION G..., manufactured by Shanghai Super Gloves Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K974120 · Shanghai Super Gloves Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
47d
Days
Class 1
Risk

K974120 is an FDA 510(k) clearance for the POWDER-FREE VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai Super Gloves Co., Ltd. (Great Neck,, US). The FDA issued a Cleared decision on December 17, 1997 after a review of 47 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 Super Gloves Co., Ltd. devices

FDA 510(k) Submission Details - K974120

510(k) Number K974120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1997
Decision Date December 17, 1997
Days to Decision 47 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 129d · This submission: 47d
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 K974120.
TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE
K992122 · Maxxim Medical · Jul 1999
SYNTEX
K971360 · Shinemound Enterprise, Inc. · Dec 1997
VINYL PATIENT EXAMINATION GLOVES (POWDERED)
K974151 · Shanghai Super Gloves Co., Ltd. · Dec 1997
VINYL PATIENT EXAMINATION GLOVES POWDERED
K973902 · Everrise Glove Products Co., Ltd. · Nov 1997
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