Cleared Traditional

K983645 - SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES

K983645 is an FDA 510(k) clearance for SYNTHETIC POWDERED VINYL PATIENT EXAMIN..., manufactured by Shijiazhuang Great Eagle Plastic Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K983645 · Shijiazhuang Great Eagle Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
49d
Days
Class 1
Risk

K983645 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 Eagle Plastic Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on December 4, 1998 after a review of 49 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shijiazhuang Great Eagle Plastic Products Co., Ltd. devices

FDA 510(k) Submission Details - K983645

510(k) Number K983645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1998
Decision Date December 04, 1998
Days to Decision 49 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
80d faster than avg
Panel avg: 129d · This submission: 49d
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 K983645.
PRE-POWDER VINYL PATIENT EXAMINATION GLOVES
K984461 · Shanghai Huamao Gloves Co., Ltd. · Feb 1999
VINYL EXAMINATION GLOVES, PREPOWDERED USP
K984094 · Trans Ancient Products Co., Ltd. · Jan 1999
PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE
K982885 · Shanghai Poseidon Plastic Products Co., Ltd. · Dec 1998
POWDERED NITRILE MEDICAL EXAMINATION GLOVE, COLORED
K983531 · Shanghai Antares Industries, Inc. · Nov 1998
POWDER FREE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVE, COLORED
K983532 · Shanghai Antares Industries, Inc. · Nov 1998
VINYL EXAMINATION GLOVES, POWDER FREE
K982933 · General Gloves Corp. · Nov 1998