FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
Sterile Latex Surgical Gloves Powder Free
K Number: K211478
·
Decision Sep 16, 2021
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
556
Applicant Total
4
Review Days
127
Basic Information
- Device Name
- Sterile Latex Surgical Gloves Powder Free
- K Number
- K211478
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 878.4460
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aspen Glove Sdn. Bhd.
- Date Received
- May 12, 2021
- Decision Date
- September 16, 2021
- Product Code
- KGO
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KGO | Surgeon'S Gloves | FDA class 1 | General, Plastic Surgery |
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