Cleared Traditional

Disposable Medical Nitrile Examination Gloves (Non sterile) (K212639) - FDA 510(k) Clearance

Class I General Hospital device.

K212639 · Jiangsu Nanfang Medical Co., Ltd. · General Hospital
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Dec 2021
Decision
110d
Days
Class 1
Risk

K212639 is an FDA 510(k) clearance for the Disposable Medical Nitrile Examination Gloves (Non sterile). Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Jiangsu Nanfang Medical Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on December 8, 2021 after a review of 110 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 Jiangsu Nanfang Medical Co., Ltd. devices

Submission Details

510(k) Number K212639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2021
Decision Date December 08, 2021
Days to Decision 110 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
19d faster than avg
Panel avg: 129d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZC Medical Glove, Specialty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon’s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.
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

Cnmed Consultant
Johnson Liu

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 - LZC Medical Glove, Specialty

All 28
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K212639.
Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs
K213910 · Changzhou Universal Medical Equipment Co., Ltd. · Mar 2022
Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs
K213325 · Anhui Xinyisheng Medical Technology Co.,Ltd · Jan 2022
AspenMed+
K213076 · Aspen Glove Sdn. Bhd. · Dec 2021
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs
K212827 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Dec 2021
Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove
K200633 · 0 & M Halyard, Inc. · Oct 2020
Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)
K201390 · Medline Industires, Inc. · Sep 2020