Cleared Traditional

Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves (K213775) - FDA 510(k) Clearance

Class I General Hospital device.

K213775 · Avecena Gloves Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
143d
Days
Class 1
Risk

K213775 is an FDA 510(k) clearance for the Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Avecena Gloves Sdn Bhd (Negeri Sembilan, MY). The FDA issued a Cleared decision on April 24, 2022 after a review of 143 days - within the typical 510(k) review window.

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 Avecena Gloves Sdn Bhd devices

Submission Details

510(k) Number K213775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2021
Decision Date April 24, 2022
Days to Decision 143 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
14d slower than avg
Panel avg: 129d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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

Medcer Uluslararasi Medikal Belgelendirme Anonim Sirketi
Mehmet Fatih Ormeci

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 - LYY Latex Patient Examination Glove

All 41
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K213775.
Examination gloves-Type A(Latex gloves)
K214017 · Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · Jul 2022
TC Gloves
K221185 · Thanh Cong Pharmaceutical and Trading Company Limited · Jun 2022
Amazing+ Latex Examination Powder Free Gloves
K212597 · Amazing Rubber Products Pvt, Ltd. · May 2022
Non-sterile, Powder-Free Latex Examination Glove
K212309 · Sri Trang Gloves (Thailand) Public Company Limited · Apr 2022
Latex Examination Gloves, Powder Free
K213509 · Shandong Intco Medical Products Co, Ltd. · Apr 2022
Goody Gloves, Wincare, TBG Gloves
K213073 · Thai Rubber Gloves Co., Ltd. · Dec 2021