Cleared Traditional

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) (K210755) - FDA 510(k) Clearance

Class I General Hospital device.

K210755 · Meditech Gloves Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2021
Decision
53d
Days
Class 1
Risk

K210755 is an FDA 510(k) clearance for the Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Meditech Gloves Sdn Bhd (Nilai, MY). The FDA issued a Cleared decision on May 7, 2021 after a review of 53 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Meditech Gloves Sdn Bhd devices

Submission Details

510(k) Number K210755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2021
Decision Date May 07, 2021
Days to Decision 53 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
76d faster than avg
Panel avg: 129d · This submission: 53d
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 K210755.
Powder Free Nitrile Examination Glove
K210369 · Pastel Glove Sdn Bhd · May 2021
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)
K203036 · Central Medicare Sdn Bhd · May 2021
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
K210366 · Onetexx Sdn Bhd · May 2021
Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)
K210944 · Harbour Health, LLC · Apr 2021
Disposable Nitrile Examination Gloves
K203436 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · Apr 2021
Powder Free Blue Nitrile Examination Glove
K203512 · Vip Glove Sdn Bhd · Apr 2021