FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
K Number: K230314
·
Decision Aug 16, 2023
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
3
Review Days
191
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Basic Information
- Device Name
- Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
- K Number
- K230314
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- New Era Medicare Sdn. Bhd.
- Date Received
- February 6, 2023
- Decision Date
- August 16, 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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