La Glove (M) Sdn. Bhd.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “La Glove (M) Sdn. Bhd.” (first 1991, latest 2010), across 4 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 |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 9 | 9 |
| LYY | Latex Patient Examination Glove | 8 | 8 |
| KGO | Surgeon'S Gloves | 4 | 4 |
| FMC | Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (22)
Most recent La Glove (M) Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093335 | LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR) | LZA | 2010-06-18 | 235 |
| K093193 | LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET) | LYY | 2010-06-08 | 238 |
| K092499 | LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET) | LYY | 2009-11-20 | 98 |
| K092498 | LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR) | LZA | 2009-11-20 | 98 |
| K042618 | LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) | FMC | 2004-11-26 | 60 |
| K010863 | LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPRENE CO-POLYMER) | LZA | 2001-05-03 | 42 |
| K010861 | LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE) | LZA | 2001-04-03 | 12 |
| K010860 | LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE) | LZA | 2001-04-03 | 12 |
| K991950 | LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE) | KGO | 1999-08-12 | 64 |
| K991949 | LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED) | KGO | 1999-08-12 | 64 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named La Glove (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.
Frequently asked questions
How many FDA 510(k) clearances are listed under La Glove (M) Sdn. Bhd.?
FDA lists 22 510(k) clearances under the applicant name “La Glove (M) Sdn. Bhd.” (first 1991, latest 2010), across 4 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 La Glove (M) Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name La Glove (M) Sdn. Bhd. is 47 days.
Which FDA product codes appear under La Glove (M) Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 9); LYY (Latex Patient Examination Glove, 8); KGO (Surgeon'S Gloves, 4).
Next steps
- See all 22 La Glove (M) Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, La Glove (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.