Cleared Traditional

K102976 - POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLORED)

K102976 is an FDA 510(k) clearance for POWDERED VINYL PATIENT EXAMINIATION GLOVES, manufactured by Heze Juxinyuan Food Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K102976 · Heze Juxinyuan Food Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
68d
Days
Class 1
Risk

K102976 is an FDA 510(k) clearance for the POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLORED). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Heze Juxinyuan Food Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on December 13, 2010 after a review of 68 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.

FDA 510(k) Submission Details - K102976

510(k) Number K102976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2010
Decision Date December 13, 2010
Days to Decision 68 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
61d faster than avg
Panel avg: 129d · This submission: 68d
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 K102976.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K102724 · Zibo Yuqun New Material Science and Technology CO · Dec 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K102977 · Heze Juxinyuan Food Co., Ltd. · Dec 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K103198 · Youngshengplastic Co., Ltd. · Dec 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K102444 · Zibo Yingbo Medical Products, Inc. · Nov 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102097 · Shijiazhuang Great Vision Plastic Products Co., LT · Nov 2010
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K102171 · Wuxi Bingfa Gainlite Gloves Cp., Ltd. · Nov 2010
K102976 · POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLORED)
Download PDF FDA Summary Heze Juxinyuan Food C…