Cleared Traditional

K081657 - POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW)

K081657 is an FDA 510(k) clearance for POWDERED VINYL PATIENT EXAMINATION GLOVES, manufactured by Jiangsu Cureguard Glove Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K081657 · Jiangsu Cureguard Glove Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
69d
Days
Class 1
Risk

K081657 is an FDA 510(k) clearance for the POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Jiangsu Cureguard Glove Co., Ltd. (Haidian District, Beijing, CN). The FDA issued a Cleared decision on August 20, 2008 after a review of 69 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 Jiangsu Cureguard Glove Co., Ltd. devices

FDA 510(k) Submission Details - K081657

510(k) Number K081657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2008
Decision Date August 20, 2008
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
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 638
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K081657.
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K081539 · Rich Mountain Medical Products, Inc. · Sep 2008
SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE
K082029 · Ever Light Plastic Products Co., Ltd. · Sep 2008
DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE
K082443 · Rich Mountain Medical Products, Inc. · Sep 2008
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K081535 · Rich Mountain Medical Products, Inc. · Aug 2008
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW)
K081655 · Jiangsu Cureguard Glove Co., Ltd. · Jul 2008
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K071999 · Tangshan Hongyun Plastic Products Co., Ltd. · May 2008