FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
Latex Examination Powder Free Gloves
K Number: K211477
·
Decision Sep 20, 2021
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
4
Review Days
131
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Basic Information
- Device Name
- Latex Examination Powder Free Gloves
- K Number
- K211477
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aspen Glove Sdn. Bhd.
- Date Received
- May 12, 2021
- Decision Date
- September 20, 2021
- Product Code
- LYY
- 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | FDA class 1 | General Hospital |
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