Cleared Traditional

K974334 - DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES

K974334 is an FDA 510(k) clearance for DISPOSABLE POWDER FREE VINYL SYNTHETIC ..., manufactured by Hong Huang Tang 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 52-day FDA review.

K974334 · Hong Huang Tang Industrial Co., Ltd. · General Hospital
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Jan 1998
Decision
52d
Days
Class 1
Risk

K974334 is an FDA 510(k) clearance for the DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Hong Huang Tang Industrial Co., Ltd. (Miao Li Hsien, TW). The FDA issued a Cleared decision on January 9, 1998 after a review of 52 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 Hong Huang Tang Industrial Co., Ltd. devices

FDA 510(k) Submission Details - K974334

510(k) Number K974334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1997
Decision Date January 09, 1998
Days to Decision 52 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
77d faster than avg
Panel avg: 129d · This submission: 52d
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 140
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K974334.
SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE
K992865 · Maxxim Medical · Oct 1999
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
POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED
K974443 · P.T. Latexindo Tobaperkasa · Jan 1998
SYNTEX
K971360 · Shinemound Enterprise, Inc. · Dec 1997
VINYL PATIENT EXAMINATION GLOVES (POWDERED)
K974151 · Shanghai Super Gloves Co., Ltd. · Dec 1997