Seal Polymer Industries Bhd.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Seal Polymer Industries Bhd.” (first 1992, latest 2004), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 43 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 | 7 | 7 |
| LZA | Polymer Patient Examination Glove | 6 | 6 |
Review panels
- General Hospital (13)
Most recent Seal Polymer Industries Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042238 | CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES | LZA | 2004-09-16 | 29 |
| K042101 | CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES | LZA | 2004-08-27 | 23 |
| K032077 | CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET) | LZA | 2003-08-19 | 43 |
| K022792 | CASHMERE POWDER FREE LATEX EXAMINATION GLOVES (POLYMER COATED ONLINE CHLORINATED) | LYY | 2002-09-26 | 35 |
| K021388 | CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRAM | LYY | 2002-06-10 | 39 |
| K020868 | CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE) | LZA | 2002-04-22 | 35 |
| K014055 | NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM ON LABELING | LYY | 2002-01-28 | 49 |
| K993326 | NON-STERILE POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (70 MICROGRAMS OR LESS PER | LYY | 1999-11-17 | 44 |
| K993134 | CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN) | LZA | 1999-11-17 | 58 |
| K993133 | CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN | LZA | 1999-11-17 | 58 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Seal Polymer Industries 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.
- Seal Syringe Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Seal Polymer Industries Bhd.?
FDA lists 13 510(k) clearances under the applicant name “Seal Polymer Industries Bhd.” (first 1992, latest 2004), 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 Seal Polymer Industries Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Seal Polymer Industries Bhd. is 43 days.
Which FDA product codes appear under Seal Polymer Industries Bhd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 7); LZA (Polymer Patient Examination Glove, 6).
Next steps
- See all 13 Seal Polymer Industries Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Seal Polymer Industries 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.