Cleared Traditional

K994099 - VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED

K994099 is an FDA 510(k) clearance for VINYL PATIENT EXAMINATION GLOVES-PRE-PO..., manufactured by Evergreen Medical Produts (Jingxing) Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K994099 · Evergreen Medical Produts (Jingxing) Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
131d
Days
Class 1
Risk

K994099 is an FDA 510(k) clearance for the VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Evergreen Medical Produts (Jingxing) Co., Ltd. (Shijiazhuang City,Hebei Prov., CN). The FDA issued a Cleared decision on April 12, 2000 after a review of 131 days - within the typical 510(k) review window.

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 Evergreen Medical Produts (Jingxing) Co., Ltd. devices

FDA 510(k) Submission Details - K994099

510(k) Number K994099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1999
Decision Date April 12, 2000
Days to Decision 131 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
2d slower than avg
Panel avg: 129d · This submission: 131d
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 K994099.
VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR
K002745 · Arista Latindo Industrial Ltd. P.T · Oct 2000
VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR
K002746 · Arista Latindo Industrial Ltd. P.T · Oct 2000
VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K994098 · Evergreen Medical Produts (Jingxing) Co., Ltd. · May 2000
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
K992554 · Shijiazhuang Great Vision Plastic Products Co., LT · Mar 2000
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K992821 · Shijiazhuang Hongxiang Plastics Products Co; , Ltd. · Mar 2000
SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW
K992979 · Shanghai Poseidon Plastic Products Co., Ltd. · Feb 2000