Cleared Traditional

K981876 - SYNTHETIC EXAMINATION GLOVE, POWDERED

K981876 is an FDA 510(k) clearance for SYNTHETIC EXAMINATION GLOVE, manufactured by Hsing YI Plastics Processing Co, Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K981876 · Hsing YI Plastics Processing Co, Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
125d
Days
Class 1
Risk

K981876 is an FDA 510(k) clearance for the SYNTHETIC EXAMINATION GLOVE, POWDERED. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Hsing YI Plastics Processing Co, Ltd. (Sparks, US). The FDA issued a Cleared decision on September 30, 1998 after a review of 125 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.

FDA 510(k) Submission Details - K981876

510(k) Number K981876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1998
Decision Date September 30, 1998
Days to Decision 125 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
4d faster than avg
Panel avg: 129d · This submission: 125d
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 K981876.
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K983207 · Shijiazhuang Great Eagle Plastic Products Co., Ltd. · Oct 1998
VINYL PATIENT EXAMINATION GLOVE, POWDERED
K981360 · Glormed Intl., Inc. · Oct 1998
DISPOSABLE VINYL EXAM GLOVES, POWDERED
K982687 · Shanghai Antares Industries, Inc. · Oct 1998
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
K982704 · Shanghai Antares Industries, Inc. · Sep 1998
VINYL PATIENT EXAMINATION POWDER FREE GLOVES, NON-STERILE
K982015 · Taian Plastics Products (Jingxing) Co., Ltd. · Aug 1998
VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED
K982257 · Taian Plastics Products (Jingxing) Co., Ltd. · Aug 1998
K981876 · SYNTHETIC EXAMINATION GLOVE, POWDERED
Download PDF FDA Summary Hsing YI Plastics Pro…