Crocker Industrial Resources Sdn. Bhd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Crocker Industrial Resources Sdn. Bhd.” (first 1989, latest 1998), across 1 product code in 1 review panel. Median 510(k) review time under this name: 131 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 | 6 | 6 |
Review panels
- General Hospital (6)
Most recent Crocker Industrial Resources Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980754 | CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G | LYY | 1998-05-18 | 81 |
| K960842 | LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED) | LYY | 1997-03-19 | 386 |
| K943858 | POWDER FREE (SILICONIZED) EXAM GLOVES | LYY | 1994-12-08 | 122 |
| K935980 | CIR LATEX GLOVES (CIR GOLD SEAL) | LYY | 1994-05-02 | 140 |
| K924419 | CIR LATEX GLOVES | LYY | 1993-02-10 | 163 |
| K892465 | NON-STERILE PATIENT EXAMINATION GLOVES | LYY | 1989-07-14 | 98 |
Recalls
openFDA lists no recalls under a recalling firm named Crocker Industrial Resources 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 Crocker Industrial Resources Sdn. Bhd.?
FDA lists 6 510(k) clearances under the applicant name “Crocker Industrial Resources Sdn. Bhd.” (first 1989, latest 1998), across 1 product code 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 Crocker Industrial Resources Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Crocker Industrial Resources Sdn. Bhd. is 131 days.
Which FDA product codes appear under Crocker Industrial Resources Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 6).
Next steps
- See all 6 Crocker Industrial Resources Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Crocker Industrial Resources 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.