Cleared Traditional

K964321 - GLOVE, PATIENT EXAMINATION, VINYL (POWDERED)

K964321 is an FDA 510(k) clearance for GLOVE, 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 72-day FDA review.

K964321 · Shijiazhuang Hongray Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
72d
Days
Class 1
Risk

K964321 is an FDA 510(k) clearance for the GLOVE, PATIENT EXAMINATION, VINYL (POWDERED). 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 January 9, 1997 after a review of 72 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 Hongray Plastic Products Co., Ltd. devices

FDA 510(k) Submission Details - K964321

510(k) Number K964321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1996
Decision Date January 09, 1997
Days to Decision 72 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 129d · This submission: 72d
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 206
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K964321.
JIAWANG PRE-POWDERED VINYL EXAMINATION GLOVES
K964800 · Shanghai Jiawang Industrial Co. , Ltd. · Feb 1997
VINYL PATIENT EXAMINATION GLOVES
K964629 · Arista Medi Prima · Feb 1997
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K964964 · Sunmax Enterprise Shanghai Co. , Ltd. · Feb 1997
POWDER FREE VINYL EXAMINATION GLOVE
K964545 · Shanghai Poseidon Plastic Products Co., Ltd. · Dec 1996
MEDLINE PRE-POWDERED NON-STERILE/STERILE VINYL EXAMINATION GLOVES
K962069 · Medline Industries, Inc. · Aug 1996
GLOVE, EXAMINATION, VINYL
K952050 · Oak Carolina, Inc. · Aug 1996