Cleared Traditional

K070026 - POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES

K070026 is an FDA 510(k) clearance for POWDERED (YELLOW) VINYL PATIENT EXAMINA..., manufactured by Shijiazhuang Lianhe Shunda Plastic Products Co., L. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K070026 · Shijiazhuang Lianhe Shunda Plastic Products Co., L · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
63d
Days
Class 1
Risk

K070026 is an FDA 510(k) clearance for the POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhuang Lianhe Shunda Plastic Products Co., L (Chino, US). The FDA issued a Cleared decision on March 7, 2007 after a review of 63 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 - K070026

510(k) Number K070026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2007
Decision Date March 07, 2007
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
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 K070026.
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
POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW
K070188 · Hong DI Plastic Products Co., Ltd. · 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
POWDERED VINYL PATIENT EXAMINATION GLOVES, YELLOW
K070042 · Super Safe Plastic Products Co., Ltd. · Feb 2007
K070026 · POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Shijiazhuang Lianhe S…