Cleared Traditional

Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) (K211810) - FDA 510(k) Clearance

Class I General Hospital device.

K211810 · Pt. Shamrock Manufacturing Corpora · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
346d
Days
Class 1
Risk

K211810 is an FDA 510(k) clearance for the Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Che.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Pt. Shamrock Manufacturing Corpora (Kab. Deli Serdang, ID). The FDA issued a Cleared decision on May 23, 2022 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Pt. Shamrock Manufacturing Corpora devices

Submission Details

510(k) Number K211810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2021
Decision Date May 23, 2022
Days to Decision 346 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
217d slower than avg
Panel avg: 129d · This submission: 346d
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 K211810.
Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color)
K220609 · Encompass Industries Sdn. Bhd. · May 2022
PP Care Nitrile Examination Gloves
K212629 · Eg Group Product and Services Co., Ltd. · May 2022
Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)
K220249 · Grand Work Plastic Products Co., Ltd. · May 2022
Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
K220155 · Motex Healthcare (Anhui) Co., Ltd. · May 2022
Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)
K212408 · Pt. Maja Agung Latexindo · May 2022
Nitrile Powder Free Examination Gloves
K220211 · Hebei Kangxida Medical Technology Development Co., Ltd. · May 2022