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)
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.

View all Hsing YI Plastics Processing Co, Ltd. devices

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 205
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