Glovco (M) Sdn. Bhd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Glovco (M) Sdn. Bhd.” (first 1999, latest 2005), 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 | 6 | 6 |
| LZA | Polymer Patient Examination Glove | 3 | 3 |
Review panels
- General Hospital (9)
Most recent Glovco (M) Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051345 | COLORED POWDER FREE AND POLYMER COATED PATIENT EXAMINATION GLOVE (PINK, BLUE, GREEN AND VIOLET) | LYY | 2005-06-23 | 31 |
| K042898 | PANTHERA N POWDER FREE BLACK NITRILE GLOVES | LZA | 2005-01-18 | 90 |
| K013828 | GLOVCO EBONY | LYY | 2002-08-13 | 267 |
| K021730 | GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE) | LZA | 2002-07-05 | 42 |
| K021308 | GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES | LZA | 2002-05-14 | 19 |
| K994013 | POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) | LYY | 2000-01-20 | 55 |
| K993752 | GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 1999-12-03 | 28 |
| K991554 | GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 1999-07-09 | 67 |
| K991043 | LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN | LYY | 1999-05-04 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Glovco (M) 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.
- Glovco Malaysia Sdn Bhd (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Glovco (M) Sdn. Bhd.?
FDA lists 9 510(k) clearances under the applicant name “Glovco (M) Sdn. Bhd.” (first 1999, latest 2005), 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 Glovco (M) Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Glovco (M) Sdn. Bhd. is 42 days.
Which FDA product codes appear under Glovco (M) Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 6); LZA (Polymer Patient Examination Glove, 3).
Next steps
- See all 9 Glovco (M) Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Glovco (M) 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.