Cleared Traditional

Vinyl Co-Polymer Powder-free Examination Gloves, Black (K220240) - FDA 510(k) Clearance

Class I General Hospital device.

K220240 · Grand Work Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
62d
Days
Class 1
Risk

K220240 is an FDA 510(k) clearance for the Vinyl Co-Polymer Powder-free Examination Gloves, Black. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Grand Work Plastic Products Co., Ltd. (Shijiazhuang, CN). The FDA issued a Cleared decision on March 31, 2022 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

Submission Details

510(k) Number K220240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2022
Decision Date March 31, 2022
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.

Device Classification

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 Consultant

Hongray USA Medical Products, Inc.
Kathy Liu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LYZ Vinyl Patient Examination Glove

All 83
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K220240.
DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
K222442 · Anhui Bytech Medical Supplies Co., Ltd. · Sep 2022
Disposable, vinyl examination gloves, Yellow
K220055 · Dezhou Hengchang Medical Technology Co., Ltd. · Aug 2022
Disposable Vinyl Examination Glove
K220469 · Chifeng Huawei Medical Science&Technology Co., Ltd. · Jun 2022
Vinyl/Nitrile Blend Exam Glove
K213634 · Dezhou Hengchang Medical Technology Co., Ltd. · Feb 2022
Vinyl Examination Gloves
K213625 · Dezhou Hengchang Medical Technology Co., Ltd. · Feb 2022
Vinyl Powder Free Examination Glove
K212011 · Top Glove Vietnam Company Limited · Feb 2022