FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves
K Number: K212349
·
Decision Dec 10, 2021
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
1
Review Days
135
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Basic Information
- Device Name
- Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves
- K Number
- K212349
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medi Legion Sdn.Bhd
- Date Received
- July 28, 2021
- Decision Date
- December 10, 2021
- 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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