FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Powder-Free Nitrile Examination Gloves
K Number: K223214
·
Decision Sep 21, 2023
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
11
Review Days
339
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Basic Information
- Device Name
- Powder-Free Nitrile Examination Gloves
- K Number
- K223214
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Global Protection Corp.
- Date Received
- October 17, 2022
- Decision Date
- September 21, 2023
- Product Code
- LZA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | FDA class 1 | General Hospital |
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Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Global Protection Corp.
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|---|---|---|---|
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| K203536 | Male Latex Condom | Sep 3, 2021 | Substantially Equivalent |
| K193578 | Non-spermicidal Lubricated Male Latex Condom | Aug 20, 2020 | Substantially Equivalent |
| K024324 | LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9 | Mar 25, 2003 | Substantially Equivalent |
| K960552 | KNIGHT LIGHT NONLUBRICATED CONDOM | Nov 20, 1997 | Substantially Equivalent |