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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 749
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K992554.
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K000953 · Shanghai Antares Industries, Inc. · Apr 2000
VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED
K994099 · Evergreen Medical Produts (Jingxing) Co., Ltd. · Apr 2000
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K000872 · Shanghai Antares Industries, Inc. · Apr 2000
BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES
K000058 · Kaohsiung Brothers Products Corp. · Mar 2000
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K992821 · Shijiazhuang Hongxiang Plastics Products Co; , Ltd. · Mar 2000
SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
K000071 · Shijiazhuang Great Eagle Plastic Products Co., Ltd. · Feb 2000
K992554 · SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Shijiazhuang Great Vi…