Cleared Traditional

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K191292) - FDA 510(k) Clearance

Class I General Hospital device.

K191292 · Anhui Powerguard Technology Co., Ltd. · General Hospital
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Nov 2019
Decision
175d
Days
Class 1
Risk

K191292 is an FDA 510(k) clearance for the Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Anhui Powerguard Technology Co., Ltd. (Jiujiang, CN). The FDA issued a Cleared decision on November 5, 2019 after a review of 175 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Anhui Powerguard Technology Co., Ltd. devices

Submission Details

510(k) Number K191292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2019
Decision Date November 05, 2019
Days to Decision 175 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
46d slower than avg
Panel avg: 129d · This submission: 175d
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

Beijing Easylink Co., Ltd.
Chu Xiaoan

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 K191292.
Disposable Vinyl Glove
K202010 · Better Health Medical Products Co., Ltd. · Oct 2020
Disposable Vinyl Glove
K202008 · Best Care Trading Co., Ltd. · Sep 2020
Medline Glide-On 3G Vinyl Examination Gloves
K192985 · Medline Industries, Inc. · Jan 2020
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
Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K182575 · Jiangxi Jaysun Medcare Co., Ltd. · May 2019