Cleared Traditional

K121992 - POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR

K121992 is an FDA 510(k) clearance for POWDER-FREE NITRILE PATIENT EXAMINATION..., manufactured by Xinwei (Shandong) Plastic and Rubber Products Co.,. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K121992 · Xinwei (Shandong) Plastic and Rubber Products Co., · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
102d
Days
Class 1
Risk

K121992 is an FDA 510(k) clearance for the POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Xinwei (Shandong) Plastic and Rubber Products Co., (Chino, US). The FDA issued a Cleared decision on October 16, 2012 after a review of 102 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.

FDA 510(k) Submission Details - K121992

510(k) Number K121992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2012
Decision Date October 16, 2012
Days to Decision 102 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
27d faster than avg
Panel avg: 129d · This submission: 102d
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 1177
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K121992.
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL
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K121992 · POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
Download PDF FDA Summary Xinwei (Shandong) Pla…