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510(k) K221748

Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves by Guilin Hbm Health Protections, Inc. — Product Code KGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2022
Date Received
June 16, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgeon'S Gloves
Device Class
Class I
Regulation Number
878.4460
Review Panel
HO
Submission Type

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 clearances by Guilin Hbm Health Protections, Inc.

  • K203483 — Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves (February 1, 2021)

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  • K222993 — Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green (August 18, 2023)