Cleared Traditional

K213934 - Pro Guard Nitrile Powder Free Examinati...

K213934 is an FDA 510(k) clearance for Pro Guard Nitrile Powder Free Examinati..., manufactured by Medical Glove Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K213934 · Medical Glove Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
233d
Days
Class 1
Risk

K213934 is an FDA 510(k) clearance for the Pro Guard Nitrile Powder Free Examination Glove. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Medical Glove Co., Ltd. (Lam Thap, TH). The FDA issued a Cleared decision on August 6, 2022 after a review of 233 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 Medical Glove Co., Ltd. devices

FDA 510(k) Submission Details - K213934

510(k) Number K213934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2021
Decision Date August 06, 2022
Days to Decision 233 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
104d slower than avg
Panel avg: 129d · This submission: 233d
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 684
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K213934.
Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl
K221164 · Hong Seng Gloves Sdn Bhd · Aug 2022
Nitrile Exam Gloves (Blue, Black)
K221143 · Hebei Astro Medical Supply Co., Ltd. · Aug 2022
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
K213937 · O&M Halyard, Inc. · Aug 2022
Powder Free Chloroprene Examination Glove Coloured (Blue, Green)
K213993 · Careglove Global Sdn. Bhd. · Aug 2022
Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K221350 · Rubberex Alliance Products Sdn Bhd · Aug 2022
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
K213929 · O&M Halyard, Inc. · Aug 2022