Cleared Traditional

K101943 - SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES

K101943 is an FDA 510(k) clearance for SYNTHETIC, manufactured by Tangshan Jiteng Plastic Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K101943 · Tangshan Jiteng Plastic Products Co., Ltd. · General Hospital
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Nov 2010
Decision
119d
Days
Class 1
Risk

K101943 is an FDA 510(k) clearance for the SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Tangshan Jiteng Plastic Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on November 8, 2010 after a review of 119 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 Tangshan Jiteng Plastic Products Co., Ltd. devices

FDA 510(k) Submission Details - K101943

510(k) Number K101943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2010
Decision Date November 08, 2010
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 129d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 Peers - LZA Polymer Patient Examination Glove

All 779
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K101943.
NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM
K103249 · Cardinal Health, Inc. · Dec 2010
POWDERFREE BLACK NITRILE EXAMINATION GLOVES
K102620 · Pt. Medisafe Technologies · Nov 2010
BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR)
K102880 · Brightway Holdings Sdn. Bhd. · Nov 2010
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG)
K102074 · Gx Corporation Sdn Bhd · Nov 2010
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K102096 · Syntex Healthcare Products Co., Ltd. · Oct 2010
NUGARD NITILE GREY COLOR
K102230 · Terang Nusa Sdn Bhd · Sep 2010