Cleared Traditional

K070187 - POWDER FREE VINYL PATIENT EXAMINATION GLOVE

K070187 is an FDA 510(k) clearance for POWDER FREE VINYL PATIENT EXAMINATION GLOVE, manufactured by Hong DI 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 22-day FDA review.

K070187 · Hong DI Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
22d
Days
Class 1
Risk

K070187 is an FDA 510(k) clearance for the POWDER FREE VINYL PATIENT EXAMINATION GLOVE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Hong DI Plastic Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on February 13, 2007 after a review of 22 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 - K070187

510(k) Number K070187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2007
Decision Date February 13, 2007
Days to Decision 22 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
107d faster than avg
Panel avg: 129d · This submission: 22d
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 K070187.
POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED)
K070076 · Jiangsu Cureguard Glove Co., Ltd. · Feb 2007
POWDER FREE VINYL PATIENT EXAMINATION GLOVE
K070037 · Shijiazhuang Lianhe Shunda Plastic Products Co., L · Feb 2007
POWDER FREE VINYL PATIENT EXAMINATION GLOVE
K070030 · Super Safe Plastic Products Co., Ltd. · Feb 2007
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K070075 · Jiangsu Cureguard Glove Co., Ltd. · Feb 2007
POWDERED VINYL PATIENT EXAMINATION GLOVES
K070008 · Zibo Hengde Plastic & Rubber Products Co., Ltd. · Feb 2007
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE
K070043 · Super Safe Plastic Products Co., Ltd. · Feb 2007
K070187 · POWDER FREE VINYL PATIENT EXAMINATION GLOVE
Download PDF FDA Summary Hong DI Plastic Produ…