Cleared Traditional

Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves (K203483) - FDA 510(k) Clearance

Class I General Hospital device.

K203483 · Guilin Hbm Health Protections, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
66d
Days
Class 1
Risk

K203483 is an FDA 510(k) clearance for the Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Guilin Hbm Health Protections, Inc. (Guilin, CN). The FDA issued a Cleared decision on February 1, 2021 after a review of 66 days - a notably fast clearance cycle.

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: 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 Guilin Hbm Health Protections, Inc. devices

Submission Details

510(k) Number K203483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2020
Decision Date February 01, 2021
Days to Decision 66 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
63d faster than avg
Panel avg: 129d · This submission: 66d
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

Landlink Healthcare Technology (Shanghai) Co., Ltd.
Shelley Li

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 96
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K203483.
POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K203030 · Wrp Asia Pacific Sdn. Bhd. · Jun 2021
ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs
K202765 · Careplus (M) Sdn Bhd · May 2021
Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein
K202401 · Eco Medi Glove Sdn. Bhd. · Feb 2021
Polyisoprene Powder Free, Black Colour Surgical Gloves
K192933 · Emerson & Co. Srl · Jan 2021
Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein
K202668 · Medline Industries, Inc. · Dec 2020
Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim
K202090 · Molnlycke Health Care Us, LLC · Nov 2020