Cleared Traditional

Syntex Exam Gloves

K253160 · Basic Medical Technology, Inc. · General Hospital
Jan 2026
Decision
119d
Days
Class 1
Risk

About This 510(k) Submission

K253160 is an FDA 510(k) clearance for the Syntex Exam Gloves, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Basic Medical Technology, Inc. (Ontario, US). The FDA issued a Cleared decision on January 23, 2026, 119 days after receiving the submission on September 26, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K253160 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2025
Decision Date January 23, 2026
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LZA — Polymer Patient Examination Glove
Device Class Class I — 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.

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