Medi-Grip (Beige 43)SURGICAL Gloves

FDA 510(k) K980564 · Ansell Perry

Substantially Equivalent

510(k) numberK980564

Submission

Device name
Medi-Grip (Beige 43)SURGICAL Gloves
Applicant
Ansell Perry
Massillon, OH, US
Received
February 13, 1998
Decision date
March 25, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KGO – Surgeon'S Gloves
Device class
Class I (low risk)
Regulation
21 CFR 878.4460
Specialty
General, Plastic Surgery

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.

Other 510(k)s with product code KGO

510(k)DeviceApplicantDecision
K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl…KGO · Traditional Hartalega NGC Sdn. Bhd.07/28/2026SE
K253060Sterile Latex Powder Free Surgical GlovesKGO · Traditional Protect Gloves Company Limited05/22/2026SE
K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With…KGO · Abbreviated Harps Europe Manufacturing GmbH08/19/2025SE
K240790Polyisoprene Surgical glovesKGO · Traditional Suzhou Colour-Way New Material Co., Ltd.08/23/2024SE
K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with…KGO · Traditional Wrp Asia Pacific Sdn. Bhd.03/28/2024SE
K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsKGO · Traditional Grand Work Plastic Products Co., Ltd.12/20/2023SE
K231902GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid…KGO · Traditional Ansell Healthcare10/20/2023SE
K231973PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical GloveKGO · Traditional Ineo Tech Sdn Bhd09/29/2023SE
K231446Single-Use Latex Sterile Surgical Gloves (SG100)KGO · Traditional Fitone Latex Products Co., Ltd. Guangdong09/22/2023SE
K230578Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with…KGO · Traditional Wrp Asia Pacific Sdn. Bhd.08/31/2023SE

More from Wrp Asia Pacific Sdn. Bhd.

510(k)DeviceDecision
K003895X-Tenda Cuff Powder Free Latex Surgical Gloves with Protein Content Labeling Claim 50…KGO · Special 01/17/2001SE
K002192Dermaguard PF Brown Powder Free Latex Surgical Gloves; Model Style 38KGO · Special 07/27/2000SE
K001239Encore Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50…KGO · Special 05/15/2000SE
K000165Next Step Powder Free Latex Examination Gloves Contains 50 MCGM or Less of Total Water…LYY · Traditional 03/10/2000SE
K000295Encore Microptic Powder Free Latex Surgical Gloves with Protein Content Labeling Claim…KGO · Special 02/16/2000SE
K993857The Original Perry, Style 42 White Latex Powdered Surgical Gloves with Protein Content…KGO · Traditional 01/31/2000SE
K992953Surgeons Glove, Brown Latex Polymer Coated, Powder Free with Protein Label ClaimKGO · Traditional 10/29/1999SE
K992156Synsation Sterile Powder Free, Polyvinyl Chloride Medical Examination GlovesLYZ · Traditional 10/27/1999SE
K992768Nitra-Touch Sterile Powder-Free Nitrile Medical Examination GloveLZA · Traditional 10/13/1999SE
K984559Elite Powder-Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use)KGO · Traditional 02/26/1999SE

Questions and answers

When was Medi-Grip (Beige 43)SURGICAL Gloves cleared by the FDA?

Medi-Grip (Beige 43)SURGICAL Gloves (K980564) received a 510(k) decision of Substantially Equivalent on March 25, 1998, 40 days after the submission was received.

What is the product code of K980564?

The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.