Sri Johani Sdn. Bhd.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Sri Johani Sdn. Bhd.” (first 1989, latest 1999), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 42 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 | 14 | 14 |
| LZA | Polymer Patient Examination Glove | 9 | 9 |
Review panels
- General Hospital (23)
Most recent Sri Johani Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993454 | POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS) | LYY | 1999-12-03 | 51 |
| K993457 | POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS] | LYY | 1999-12-02 | 50 |
| K993458 | POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) | LYY | 1999-11-10 | 28 |
| K981039 | POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) | LZA | 1998-04-21 | 33 |
| K980039 | POWDERED GREEN LATEX EXAMINATION GLOVES | LYY | 1998-02-09 | 35 |
| K980038 | POWDERFREE GREEN LATEX EXAMINATION GLOVES | LYY | 1998-02-09 | 35 |
| K980037 | POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) | LYY | 1998-02-09 | 35 |
| K974886 | POWDERED GREEN NITRILE EXAMINATION GLOVES | LZA | 1998-01-30 | 31 |
| K974887 | POWDERFREE GREEN NITRILE EXAMINATION GLOVES | LZA | 1998-01-29 | 30 |
| K974185 | POLYMER NITRILE EXAMINATION GLOVES | LZA | 1997-12-18 | 42 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sri Johani 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 Sri Johani Sdn. Bhd.?
FDA lists 23 510(k) clearances under the applicant name “Sri Johani Sdn. Bhd.” (first 1989, latest 1999), 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 Sri Johani Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sri Johani Sdn. Bhd. is 42 days.
Which FDA product codes appear under Sri Johani Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 14); LZA (Polymer Patient Examination Glove, 9).
Next steps
- See all 23 Sri Johani Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Sri Johani 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.