Cleared Traditional

Disposable Sterilized Latex Surgical Gloves (K211953) - FDA 510(k) Clearance

Class I General Hospital device.

K211953 · Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
336d
Days
Class 1
Risk

K211953 is an FDA 510(k) clearance for the Disposable Sterilized Latex Surgical Gloves. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. (Nanchang, CN). The FDA issued a Cleared decision on May 25, 2022 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - 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. Elevated predicate reliance profile. 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 K211953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2021
Decision Date May 25, 2022
Days to Decision 336 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
207d slower than avg
Panel avg: 129d · This submission: 336d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGO Surgeon's Gloves
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, 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 - KGO Surgeon's Gloves

All 96
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K211953.
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