Cleared Traditional

Proclean - Nitrile Powder Free Examination Gloves (K211374) - FDA 510(k) Clearance

Class I General Hospital device.

K211374 · Dr.Boo Company Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2021
Decision
162d
Days
Class 1
Risk

K211374 is an FDA 510(k) clearance for the Proclean - Nitrile Powder Free Examination Gloves. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Dr.Boo Company Limited (Sriracha, TH). The FDA issued a Cleared decision on October 13, 2021 after a review of 162 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 Dr.Boo Company Limited devices

Submission Details

510(k) Number K211374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2021
Decision Date October 13, 2021
Days to Decision 162 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
33d slower than avg
Panel avg: 129d · This submission: 162d
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 K211374.
Medical Examination Gloves
K212311 · Guangzhou Junda Gloves Co., Ltd. · Oct 2021
Nitrile Examination Gloves
K210706 · Niujian Technology Co., Ltd. · Oct 2021
Nitrile Patient Examination Gloves
K211914 · Yingxiang Glove Products Co., Ltd. · Oct 2021
Medical Nitrile Examination Gloves
K212014 · Jiangxi Ronglai Medical Technology Co., Ltd. · Oct 2021
Nitrile examination gloves
K211927 · Fitone Latex Products Co., Ltd. Guangdong · Oct 2021
Medical Examination Gloves
K212078 · Guangdong Gymda Medical Technology Co.,Ltd · Oct 2021