Search Results
Found 2 results
510(k) Data Aggregation
K Number
K221748Device Name
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
Manufacturer
Date Cleared
2022-09-13
(89 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Guilin HBM Health Protections, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
K Number
K203483Device Name
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
Manufacturer
Date Cleared
2021-02-01
(66 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Guilin HBM Health Protections, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Medispo Rubber/Polyisoprene surgical gloves are sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination.
Device Description
The proposed devices, surgical gloves, are sterile and disposable devices. There are two types of surgical gloves according to the raw materials in this submission:
- Type 1-Natural rubber surgical gloves .
- Type 2-Synthetic polyisoprene surgical gloves .
The proposed devices are powder-free gloves with creamy white in color. There are seven sizes (6", 6.5", 7", 7.5", 8", 8.5", 9") available for the gloves whichever are smooth- or texture-surfaced, with or without a rolled rim at the cuff edge.
The gloves are sterilized by ionizing irradiation. The shelf-life is three (3) years.
Ask a Question
Ask a specific question about this device
Page 1 of 1