Cleared Traditional

Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) (K211621) - FDA 510(k) Clearance

Class I General Hospital device.

K211621 · Careplus (M) Sdn Bhd · General Hospital
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Oct 2021
Decision
133d
Days
Class 1
Risk

K211621 is an FDA 510(k) clearance for the Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less). Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Careplus (M) Sdn Bhd (Seremban, MY). The FDA issued a Cleared decision on October 6, 2021 after a review of 133 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - 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 Careplus (M) Sdn Bhd devices

Submission Details

510(k) Number K211621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2021
Decision Date October 06, 2021
Days to Decision 133 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 129d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGO Surgeon's Gloves
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, 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 - KGO Surgeon's Gloves

All 96
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K211621.
Sterile Latex Surgical Gloves Powder Free
K212596 · Amazing Rubber Products Pvt, Ltd. · Mar 2022
Sterile Latex Surgical Gloves Powder Free
K212848 · Pentavest Holdings Sdn Bhd · Dec 2021
Nulife
K210969 · Mrk Healthcare Pvt, Ltd. · Nov 2021
Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
K201592 · Cardinal Health200, LLC · Sep 2021
Sterile Latex Surgical Gloves Powder Free
K211478 · Aspen Glove Sdn. Bhd. · Sep 2021
ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
K210724 · Careplus (M) Sdn Bhd · Aug 2021