Top Glove Sdn. Bhd.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Top Glove Sdn. Bhd.” (first 1991, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 69 days. Since 2017 the median was 205 days, against 114 days for all cleared 510(k)s in the same product codes. 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 | 1 | 64 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 164 |
| 2018 | 1 | 213 |
| 2019 | 0 | — |
| 2020 | 2 | 300 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 48 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Top Glove Sdn. Bhd. took a median 205 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 8 | 8 |
| LZA | Polymer Patient Examination Glove | 7 | 7 |
| LYZ | Vinyl Patient Examination Glove | 2 | 2 |
| KGO | Surgeon'S Gloves | 1 | 1 |
Review panels
- General Hospital (18)
Most recent Top Glove Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262542 | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim | LZA | 2026-09-09 | 48 |
| K192111 | Biodegradable Nitrile Examination Powder Free Glove, Green | LZA | 2020-09-03 | 395 |
| K193150 | Latex Examination Powder Free Glove, Aloe Vera | LZA | 2020-06-05 | 205 |
| K172923 | Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue | LZA | 2018-04-26 | 213 |
| K171279 | Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves | KGO | 2017-10-12 | 164 |
| K122999 | POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | 2012-11-30 | 64 |
| K023974 | ALOE VERA & VITAMIN E POWDERFREE LATEX EXAMINATION GLOVES | LYY | 2003-02-13 | 73 |
| K021855 | TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS) | LYY | 2002-08-05 | 60 |
| K993664 | SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES | LYZ | 2000-01-11 | 74 |
| K993605 | PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES | LYY | 1999-12-20 | 56 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Top Glove 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 Top Glove Sdn. Bhd.?
FDA lists 18 510(k) clearances under the applicant name “Top Glove Sdn. Bhd.” (first 1991, latest 2026), 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 Top Glove Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Top Glove Sdn. Bhd. is 69 days. Since 2017: 205 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Top Glove Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 8); LZA (Polymer Patient Examination Glove, 7); LYZ (Vinyl Patient Examination Glove, 2).
Next steps
- See all 18 Top Glove Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Top Glove 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.