Alliance Rubber Products Sdn. Bhd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Alliance Rubber Products Sdn. Bhd.” (first 1990, latest 2000), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 66 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 |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 7 | 7 |
| LYY | Latex Patient Examination Glove | 5 | 5 |
Review panels
- General Hospital (12)
Most recent Alliance Rubber Products Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002701 | POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS) | LYY | 2000-09-13 | 14 |
| K992870 | POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI | LYY | 1999-10-15 | 50 |
| K991981 | NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR | LZA | 1999-08-05 | 52 |
| K990486 | NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR. | LZA | 1999-04-23 | 66 |
| K990485 | NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR | LZA | 1999-04-23 | 66 |
| K990427 | ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE | LZA | 1999-04-23 | 71 |
| K990453 | NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR | LZA | 1999-03-09 | 25 |
| K983146 | ARSOFT | LZA | 1998-12-07 | 90 |
| K980589 | AR SAFE NITRILE EXAMINATION GLOVES | LZA | 1998-04-14 | 56 |
| K972801 | ALLIANCE RUBBER, EC-GRIP | LYY | 1997-10-21 | 85 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Alliance Rubber Products 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Alliance Medical Corp. (47 510(k)s)
- Alliance Partners, LLC (10 510(k)s)
- Alliance Global Technology Co., Ltd. (2 510(k)s)
- Alliance International Co., Ltd. (2 510(k)s)
- Alliance Pharmaceutical Corp. (2 510(k)s)
- Alliance Global (1 510(k)s)
- Alliance Instruments (1 510(k)s)
- Alliance Medical Marketinig (1 510(k)s)
- Alliance Tech Medical, Inc. (1 510(k)s)
- Alliance Medical Technologies, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alliance Rubber Products Sdn. Bhd.?
FDA lists 12 510(k) clearances under the applicant name “Alliance Rubber Products Sdn. Bhd.” (first 1990, latest 2000), across 2 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 Alliance Rubber Products Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alliance Rubber Products Sdn. Bhd. is 66 days.
Which FDA product codes appear under Alliance Rubber Products Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 7); LYY (Latex Patient Examination Glove, 5).
Next steps
- See all 12 Alliance Rubber Products Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Alliance Rubber Products 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.