Ampri Rubberware Industries Sdn Bhd
Lumpur, Malaysia, MY
Ampri Rubberware Industries Sdn Bhd appears in FDA device records in Lumpur, Malaysia, MY. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Ampri Rubberware Industries Sdn Bhd between 1989 and 1999. The busiest year on record is 1995, with 3. The most recent is 1999, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 2 |
| 1995 | 3 |
| 1996 | 1 |
| 1999 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K990677 | ABSOGEL CHEMOTHERAPHY GLOVES | LZC | Substantially Equivalent | |
| K990812 | POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTA | LYY | Substantially Equivalent | |
| K954002 | AMPRI | KGO | Substantially Equivalent | |
| K952833 | AMPRI | LYY | Substantially Equivalent | |
| K945948 | ABSOGEL STERILE POWDER-FREE SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K946056 | ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE) | LYY | Substantially Equivalent | |
| K892176 | CORRECT TOUCH SURGEONS GLOVES | KGO | Substantially Equivalent | |
| K892175 | CORRECT TOUCH EXAMINATION GLOVES (LATEX) | LYY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain