Cleared Traditional

K992554 - SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES

K992554 is an FDA 510(k) clearance for SYNTHETIC POWDERED VINYL PATIENT EXAMIN..., manufactured by Shijiazhuang Great Vision Plastic Products Co., LT. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K992554 · Shijiazhuang Great Vision Plastic Products Co., LT · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
243d
Days
Class 1
Risk

K992554 is an FDA 510(k) clearance for the SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhuang Great Vision Plastic Products Co., LT (Chino, US). The FDA issued a Cleared decision on March 29, 2000 after a review of 243 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 Shijiazhuang Great Vision Plastic Products Co., LT devices

FDA 510(k) Submission Details - K992554

510(k) Number K992554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1999
Decision Date March 29, 2000
Days to Decision 243 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 129d · This submission: 243d
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 142
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K992554.
MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW
K003091 · Medline Industries, Inc. · Oct 2000
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
SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES
K993664 · Top Glove Sdn. Bhd. · Jan 2000
SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE
K993680 · Top Glove Sdn. Bhd. · Dec 1999
SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES
K992156 · Ansell Perry · Oct 1999