Cleared Traditional

K974777 - VINYL EXAMINATION GLOVES POWDER FREE

K974777 is an FDA 510(k) clearance for VINYL EXAMINATION GLOVES POWDER FREE, manufactured by Sun Flower 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 39-day FDA review.

K974777 · Sun Flower Gloves Co., Ltd. · General Hospital
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Jan 1998
Decision
39d
Days
Class 1
Risk

K974777 is an FDA 510(k) clearance for the VINYL EXAMINATION GLOVES POWDER FREE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Sun Flower Gloves Co., Ltd. (Hayward, US). The FDA issued a Cleared decision on January 30, 1998 after a review of 39 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 Sun Flower Gloves Co., Ltd. devices

FDA 510(k) Submission Details - K974777

510(k) Number K974777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1997
Decision Date January 30, 1998
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
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 205
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K974777.
SENSITEX EXAMINATION GLOVE
K981963 · Oak Carolina, Inc. · Jul 1998
GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION
K981488 · Oak Carolina, Inc. · Jul 1998
DISPOSABLE SYNTHETIC PATIENT EXMINATION GLOVES, POWDER FREE
K980093 · Universal Gloves Corp. · Mar 1998
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES
K974334 · Hong Huang Tang Industrial Co., Ltd. · Jan 1998
POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED
K974443 · P.T. Latexindo Tobaperkasa · Jan 1998
SYNTEX
K971360 · Shinemound Enterprise, Inc. · Dec 1997