Cleared Traditional

K982720 - H-RAY

K982720 is an FDA 510(k) clearance for H-RAY, manufactured by Shijiazhuang Hongray 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 93-day FDA review.

K982720 · Shijiazhuang Hongray Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
93d
Days
Class 1
Risk

K982720 is an FDA 510(k) clearance for the H-RAY. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhuang Hongray Plastic Products Co., Ltd. (Shijiazhuang, CN). The FDA issued a Cleared decision on November 5, 1998 after a review of 93 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 Shijiazhuang Hongray Plastic Products Co., Ltd. devices

FDA 510(k) Submission Details - K982720

510(k) Number K982720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1998
Decision Date November 05, 1998
Days to Decision 93 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
36d faster than avg
Panel avg: 129d · This submission: 93d
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 K982720.
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
VINYL EXAM GLOVES, POWDER FREE
K983494 · Glormed Intl., Inc. · Nov 1998
POWDER-FREE NON STERILE VINYL EXAMINATION GLOVES
K983612 · Shanghai Jiatai Plastic Products Co., Ltd. · Nov 1998
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K983207 · Shijiazhuang Great Eagle Plastic Products Co., Ltd. · Oct 1998