FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇳 India
Sterile Latex Surgical Gloves Powder Free
K Number: K212596
·
Decision Mar 1, 2022
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
558
Applicant Total
4
Review Days
197
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Basic Information
- Device Name
- Sterile Latex Surgical Gloves Powder Free
- K Number
- K212596
- 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
- Amazing Rubber Products Pvt, Ltd.
- Date Received
- August 16, 2021
- Decision Date
- March 1, 2022
- 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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