Cleared Traditional

Examination gloves-Type A(Latex gloves) (K214017) - FDA 510(k) Clearance

Class I General Hospital device.

K214017 · Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · General Hospital
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Jul 2022
Decision
204d
Days
Class 1
Risk

K214017 is an FDA 510(k) clearance for the Examination gloves-Type A(Latex gloves). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. (Nanchang, CN). The FDA issued a Cleared decision on July 14, 2022 after a review of 204 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 Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. devices

Submission Details

510(k) Number K214017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2021
Decision Date July 14, 2022
Days to Decision 204 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
75d slower than avg
Panel avg: 129d · This submission: 204d
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

Shanghai Mind-Link Business Consulting Co., Ltd.
Alice Huang

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 K214017.
Iconic Latex Glove
K221648 · Iconic Medicare Sdn Bhd · Aug 2022
Powder Free Latex Examination Glove, Non-Sterile
K211601 · Wrp Asia Pacific Sdn. Bhd. · Aug 2022
Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
K212482 · Sri Trang Gloves (Thailand) Public Company Limited · Aug 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
Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves
K213775 · Avecena Gloves Sdn Bhd · Apr 2022