FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
AMPRI
K Number: K954002
·
Decision Jan 29, 1996
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
558
Applicant Total
8
Review Days
157
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Basic Information
- Device Name
- AMPRI
- K Number
- K954002
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4460
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ampri Rubberware Industries Sdn Bhd
- Date Received
- August 25, 1995
- Decision Date
- January 29, 1996
- 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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Other Clearances by Ampri Rubberware Industries Sdn Bhd
| K Number | Device Name | ||
|---|---|---|---|
| K990677 | ABSOGEL CHEMOTHERAPHY GLOVES | Nov 1, 1999 | Substantially Equivalent |
| K990812 | POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTA | May 4, 1999 | Substantially Equivalent |
| K952833 | AMPRI | Sep 5, 1995 | Substantially Equivalent |
| K945948 | ABSOGEL STERILE POWDER-FREE SURGICAL GLOVES | Jul 31, 1995 | Substantially Equivalent |
| K946056 | ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE) | Jul 20, 1995 | Substantially Equivalent |
| K892176 | CORRECT TOUCH SURGEONS GLOVES | Sep 6, 1989 | Substantially Equivalent |
| K892175 | CORRECT TOUCH EXAMINATION GLOVES (LATEX) | Aug 25, 1989 | Substantially Equivalent |