Cleared Traditional

K070188 - POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW

K070188 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 56-day FDA review.

K070188 · 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
Mar 2007
Decision
56d
Days
Class 1
Risk

K070188 is an FDA 510(k) clearance for the POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW. 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 March 19, 2007 after a review of 56 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 - K070188

510(k) Number K070188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2007
Decision Date March 19, 2007
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
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 K070188.
POWDERED FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
K070041 · Shijiazhuang Lianhe Shunda Plastic Products Co., L · Mar 2007
POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW
K070038 · Super Safe Plastic Products Co., Ltd. · Mar 2007
POWDERED (WHITE) VINYL PATIENT EXAMINATION
K070027 · Shijiazhuang Lianhe Shunda Plastic Products Co., L · Mar 2007
POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K070026 · Shijiazhuang Lianhe Shunda Plastic Products Co., L · Mar 2007
SHIJIAZHUANG JUNFEI PLASTICS PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
K063471 · Shijiazhuang Junfei Plastic Products Co., Ltd. · Feb 2007
POWDERED VINYL PATIENT EXAMINATION GLOVES
K070145 · Wuxi Shenzhou Plastic Products Co., Ltd. · Feb 2007
K070188 · POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW
Download PDF FDA Summary Hong DI Plastic Produ…