Cleared Traditional

K010626 - POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES

K010626 is an FDA 510(k) clearance for POWDER FREE (YELLOW) VINYL PATIENT EXAM..., manufactured by Shijiazhuang Junfei 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 52-day FDA review.

K010626 · Shijiazhuang Junfei Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
52d
Days
Class 1
Risk

K010626 is an FDA 510(k) clearance for the POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhuang Junfei Plastic Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on April 23, 2001 after a review of 52 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 - K010626

510(k) Number K010626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2001
Decision Date April 23, 2001
Days to Decision 52 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
77d faster than avg
Panel avg: 129d · This submission: 52d
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 K010626.
POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K011474 · Shijiazhuang Junfei Plastic Products Co., Ltd. · May 2001
POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES
K011186 · Allegiance Healthcare Corp. · May 2001
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K010627 · Shijiazhuang Junfei Plastic Products Co., Ltd. · Apr 2001
POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K010628 · Shijiazhuang Junfei Plastic Products Co., Ltd. · Apr 2001
POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
K010671 · Tong Ruhn Medical Products Co., Ltd. · Apr 2001
POWDER FREE TEXTURED VINYL EXAMINATION GLOVES
K010830 · General Gloves Corp. · Apr 2001
K010626 · POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Shijiazhuang Junfei P…