Cleared Abbreviated

K052612 - DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR

K052612 is an FDA 510(k) clearance for DISPOSABLE POWDER FREE VINYL EXAM GLOVE..., manufactured by Shanghai Antares Industries, Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Abbreviated 510(k) pathway after a 61-day FDA review.

K052612 · Shanghai Antares Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
61d
Days
Class 1
Risk

K052612 is an FDA 510(k) clearance for the DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANO.... Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai Antares Industries, Inc. (Songjiang County, Shanghai, CN). The FDA issued a Cleared decision on November 22, 2005 after a review of 61 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Shanghai Antares Industries, Inc. devices

FDA 510(k) Submission Details - K052612

510(k) Number K052612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2005
Decision Date November 22, 2005
Days to Decision 61 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 129d · This submission: 61d
Pathway characteristics
Standards-based clearance path.

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 K052612.
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102094 · Grand Work Plastic Products Co., Ltd. · Oct 2010
VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR
K061562 · Grand Work Plastic Products Co., Ltd. · Jul 2006
ESTEEM STRETCHY VINYL GLOVE WITH COATING
K052568 · Cardinalhealth · Nov 2005
POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING
K051683 · Shen Wei (Usa), Inc. · Aug 2005
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES
K042830 · Grand Work Plastic Products Co., Ltd. · Nov 2004
SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K040682 · Grand Work Plastic Products Co., Ltd. · Jul 2004