Ampri Rubberware Industries Sdn Bhd: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Ampri Rubberware Industries Sdn Bhd” (first 1989, latest 1999), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 156 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 4 | 4 |
| KGO | Surgeon'S Gloves | 3 | 3 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
- General Hospital (8)
Most recent Ampri Rubberware Industries Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990677 | ABSOGEL CHEMOTHERAPHY GLOVES | LZC | 1999-11-01 | 244 |
| K990812 | POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTA | LYY | 1999-05-04 | 54 |
| K954002 | AMPRI | KGO | 1996-01-29 | 157 |
| K952833 | AMPRI | LYY | 1995-09-05 | 77 |
| K945948 | ABSOGEL STERILE POWDER-FREE SURGICAL GLOVES | KGO | 1995-07-31 | 237 |
| K946056 | ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE) | LYY | 1995-07-20 | 226 |
| K892176 | CORRECT TOUCH SURGEONS GLOVES | KGO | 1989-09-06 | 154 |
| K892175 | CORRECT TOUCH EXAMINATION GLOVES (LATEX) | LYY | 1989-08-25 | 142 |
Recalls
openFDA lists no recalls under a recalling firm named Ampri Rubberware Industries Sdn Bhd.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ampri Rubberware Industries Sdn Bhd?
FDA lists 8 510(k) clearances under the applicant name “Ampri Rubberware Industries Sdn Bhd” (first 1989, latest 1999), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ampri Rubberware Industries Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ampri Rubberware Industries Sdn Bhd is 156 days.
Which FDA product codes appear under Ampri Rubberware Industries Sdn Bhd?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 4); KGO (Surgeon'S Gloves, 3); LZC (Medical Glove, Specialty, 1).
Next steps
- See all 8 Ampri Rubberware Industries Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LYY, Ampri Rubberware Industries Sdn Bhd's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.