FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
ABSOGEL CHEMOTHERAPHY GLOVES
K Number: K990677
·
Decision Nov 1, 1999
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
78
Applicant Total
8
Review Days
244
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Basic Information
- Device Name
- ABSOGEL CHEMOTHERAPHY GLOVES
- K Number
- K990677
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ampri Rubberware Industries Sdn Bhd
- Date Received
- March 2, 1999
- Decision Date
- November 1, 1999
- Product Code
- LZC
- 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 |
|---|---|---|---|
| LZC | Medical Glove, Specialty | FDA class 1 | General Hospital |
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Other Clearances by Ampri Rubberware Industries Sdn Bhd
| K Number | Device Name | ||
|---|---|---|---|
| K990812 | POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTA | May 4, 1999 | Substantially Equivalent |
| K954002 | AMPRI | Jan 29, 1996 | 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 |