Cleared Traditional

K102089 - GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES

K102089 is an FDA 510(k) clearance for GRAND WORK PLASTIC PRODUCTS CO., manufactured by Grand Work 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 62-day FDA review.

K102089 · Grand Work Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
62d
Days
Class 1
Risk

K102089 is an FDA 510(k) clearance for the GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION G.... Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Grand Work Plastic Products Co., Ltd. (Zanhuang County, CN). The FDA issued a Cleared decision on October 6, 2010 after a review of 62 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 Grand Work Plastic Products Co., Ltd. devices

FDA 510(k) Submission Details - K102089

510(k) Number K102089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2010
Decision Date October 06, 2010
Days to Decision 62 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
67d faster than avg
Panel avg: 129d · This submission: 62d
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 639
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K102089.
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K102570 · Tangshan Kangjie Glove Co., Ltd. · Oct 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K102611 · Shijiazhuang Hyland Plastic Co., Ltd. · Oct 2010
BLUE SAIL INNOVATION
K102161 · Shandong Blue Sail Innovation Co., Ltd. · Oct 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102099 · Hong DI Plastic Products Co., Ltd. · Oct 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102094 · Grand Work Plastic Products Co., Ltd. · Oct 2010
STRETCH VINYL EXAMINATION GLOVE POWDER FREE
K102160 · Shandong Blue Sail Innovation Co., Ltd. · Oct 2010