Cleared Traditional

Best Glove-Nitrile Powder Free Examination Glove (K210249) - FDA 510(k) Clearance

Class I General Hospital device.

K210249 · Bestsafe Glove Co., Ltd. · General Hospital
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Oct 2021
Decision
269d
Days
Class 1
Risk

K210249 is an FDA 510(k) clearance for the Best Glove-Nitrile Powder Free Examination Glove. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Bestsafe Glove Co., Ltd. (Muang Rayong, TH). The FDA issued a Cleared decision on October 25, 2021 after a review of 269 days - an extended review cycle.

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 Bestsafe Glove Co., Ltd. devices

Submission Details

510(k) Number K210249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2021
Decision Date October 25, 2021
Days to Decision 269 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
140d slower than avg
Panel avg: 129d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 489
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K210249.
Examination gloves -Type C (Nitrile gloves)
K212290 · Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · Oct 2021
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
K211604 · Shanxi Hongjin Plastic Technology Co., Ltd. · Oct 2021
Disposable Medical Nitrile Examination Gloves
K212363 · Lanhuo Medical Technology (Jiangsu) Co.,Ltd · Oct 2021
Disposable Nitrile Examination Glove
K212401 · Inner Mongolia Cureguard Medical Technology Co., Ltd. · Oct 2021
Medical Examination Gloves
K212311 · Guangzhou Junda Gloves Co., Ltd. · Oct 2021
Nitrile Examination Gloves
K210706 · Niujian Technology Co., Ltd. · Oct 2021