Seal Polymer Industries Bhd.
Lahat, Ipoh, Perak, MY
Seal Polymer Industries Bhd. appears in FDA device records in Lahat, Ipoh, Perak, MY. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Seal Polymer Industries Bhd. between 1992 and 2004. The busiest year on record is 1999, with 4. The most recent is 2004, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1993 | 1 |
| 1999 | 4 |
| 2002 | 4 |
| 2003 | 1 |
| 2004 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K042238 | CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K042101 | CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K032077 | CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET) | LZA | Substantially Equivalent | |
| K022792 | CASHMERE POWDER FREE LATEX EXAMINATION GLOVES (POLYMER COATED ONLINE CHLORINATED) | LYY | Substantially Equivalent | |
| K021388 | CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRAM | LYY | Substantially Equivalent | |
| K020868 | CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE) | LZA | Substantially Equivalent | |
| K014055 | NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM ON LABELING | LYY | Substantially Equivalent | |
| K993326 | NON-STERILE POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (70 MICROGRAMS OR LESS PER | LYY | Substantially Equivalent | |
| K993134 | CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN) | LZA | Substantially Equivalent | |
| K993133 | CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN | LZA | Substantially Equivalent | |
| K991849 | NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC | LYY | Substantially Equivalent | |
| K915607 | PATIENT EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K921376 | PATIENT EXAMINATION GLOVES | LYY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain