Besglove Medicare Sdn. Bhd.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Besglove Medicare Sdn. Bhd.” (first 1997, latest 2000), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 47 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 | 13 | 13 |
| LZA | Polymer Patient Examination Glove | 9 | 9 |
Review panels
- General Hospital (22)
Most recent Besglove Medicare Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K994082 | POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS) | LYY | 2000-01-28 | 56 |
| K993500 | POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS) | LYY | 1999-12-02 | 48 |
| K993502 | POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS) | LYY | 1999-11-24 | 40 |
| K993495 | POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS) | LYY | 1999-11-24 | 40 |
| K982286 | POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) | LYY | 1998-08-11 | 42 |
| K981879 | POWDERED NITRILE EXAMINATION GLOVES | LZA | 1998-08-11 | 75 |
| K981878 | POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED) | LZA | 1998-08-11 | 75 |
| K981877 | NITRILE POWDERFREE EXAMINATION GLOVES | LZA | 1998-08-11 | 75 |
| K982285 | POWDERFREE GREEN LATEX EXAMINATION GLOVES | LYY | 1998-08-03 | 34 |
| K982284 | POWDERED GREEN LATEX EXAMINATION GLOVES | LYY | 1998-08-03 | 34 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Besglove Medicare 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.
- Besglove Healthcare Sdn. Bhd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Besglove Medicare Sdn. Bhd.?
FDA lists 22 510(k) clearances under the applicant name “Besglove Medicare Sdn. Bhd.” (first 1997, 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 Besglove Medicare Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Besglove Medicare Sdn. Bhd. is 47 days.
Which FDA product codes appear under Besglove Medicare Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 13); LZA (Polymer Patient Examination Glove, 9).
Next steps
- See all 22 Besglove Medicare Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Besglove Medicare 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.