Perusahaan Getah Asas Sdn. Bhd.: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “Perusahaan Getah Asas Sdn. Bhd.” (first 1989, latest 2010), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 50 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 | 16 | 16 |
| LZA | Polymer Patient Examination Glove | 11 | 11 |
| LZC | Medical Glove, Specialty | 3 | 3 |
Review panels
- General Hospital (30)
Most recent Perusahaan Getah Asas Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102790 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG | LZC | 2010-11-29 | 63 |
| K042805 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE | LZC | 2004-12-16 | 65 |
| K032374 | POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED | LZC | 2003-10-22 | 82 |
| K031768 | BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED | LZA | 2003-08-01 | 53 |
| K031625 | POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED | LZA | 2003-08-01 | 66 |
| K031591 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED | LZA | 2003-06-26 | 36 |
| K031414 | POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE | LYY | 2003-06-26 | 52 |
| K031021 | CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE | LYY | 2003-06-13 | 74 |
| K030333 | LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM | LYY | 2003-03-21 | 49 |
| K030331 | ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM | LYY | 2003-03-21 | 49 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Perusahaan Getah Asas 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.
- Perusahaan Pelindung Getah (M) Sdn Bhd (8 510(k)s)
- Perusahaan Intan Emas Sdn. Bhd. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Perusahaan Getah Asas Sdn. Bhd.?
FDA lists 30 510(k) clearances under the applicant name “Perusahaan Getah Asas Sdn. Bhd.” (first 1989, latest 2010), 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 Perusahaan Getah Asas Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Perusahaan Getah Asas Sdn. Bhd. is 50 days.
Which FDA product codes appear under Perusahaan Getah Asas Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 16); LZA (Polymer Patient Examination Glove, 11); LZC (Medical Glove, Specialty, 3).
Next steps
- See all 30 Perusahaan Getah Asas Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Perusahaan Getah Asas 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.