Cleared Traditional

K222058 - Polyisoprene Surgical Glove

K222058 is the FDA 510(k) clearance for Polyisoprene Surgical Glove by Wrp Asia Pacific Sdn. Bhd.. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K222058 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 2022
Decision
102d
Days
Class 1
Risk

K222058 is an FDA 510(k) clearance for the Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemot.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Wrp Asia Pacific Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on October 22, 2022 after a review of 102 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 Wrp Asia Pacific Sdn. Bhd. devices

Submission Details

510(k) Number K222058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2022
Decision Date October 22, 2022
Days to Decision 102 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
27d faster than avg
Panel avg: 129d · This submission: 102d
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 Consultant

Wrp USA, Inc.
Michael Scaglione

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KGO Surgeon's Gloves

All 164
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K222058.
Sterile Nitrile Surgical Gloves Powder Free
K222350 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Apr 2023
Sterilized Latex Surgical Gloves
K222620 · Suzhou Colour-Way New Material Co., Ltd. · Mar 2023
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K221424 · New Era Medicare Sdn. Bhd. · Jan 2023
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)
K221718 · Hartalega NGC Sdn. Bhd. · Sep 2022
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
K221748 · Guilin Hbm Health Protections, Inc. · Sep 2022
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs
K214074 · Hartalega NGC Sdn. Bhd. · May 2022