Cleared Traditional

K192985 - Medline Glide-On 3G Vinyl Examination G...

K192985 is the FDA 510(k) clearance for Medline Glide-On 3G Vinyl Examination G... by Medline Industries, Inc.. It is a Class 1 General Hospital device (product code LYZ) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K192985 · Medline Industries, Inc. · General Hospital
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Jan 2020
Decision
88d
Days
Class 1
Risk

K192985 is an FDA 510(k) clearance for the Medline Glide-On 3G Vinyl Examination Gloves. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on January 21, 2020 after a review of 88 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K192985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2019
Decision Date January 21, 2020
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
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 Peers - LYZ Vinyl Patient Examination Glove

All 90
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K192985.
Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs)
K202179 · Medline Industries, Inc. · Oct 2020
Disposable Vinyl Glove
K202010 · Better Health Medical Products Co., Ltd. · Oct 2020
Disposable Vinyl Glove
K202008 · Best Care Trading Co., Ltd. · Sep 2020
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K191292 · Anhui Powerguard Technology Co., Ltd. · Nov 2019
Powder-Free Vinyl Patient Examination Gloves, Yellow Color
K191092 · Anhui Intco Medical Products Co., Ltd. · Jul 2019
Powder-Free Clear Vinyl Patient Examination Gloves
K190095 · Anhui Intco Medical Products Co., Ltd. · Jun 2019