Contract Latex Dippers Sdn Bhd
Batang Kali, Selangor, MY
Contract Latex Dippers Sdn Bhd appears in FDA device records in Batang Kali, Selangor, MY. FDA records list 5 510(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
- 5
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 5 510(k) clearances for Contract Latex Dippers Sdn Bhd between 1994 and 2001. The busiest year on record is 1996, with 2. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1996 | 2 |
| 1998 | 1 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K011012 | POWDER FREE NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | |
| K983568 | OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM OR/LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER | LYY | Substantially Equivalent | |
| K955947 | OSTAR EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K954063 | GLOVE SEAL & SET-RITE | LYY | Substantially Equivalent | |
| K934316 | GLOVE SEAL, POWDER FREE LATEX 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
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Data as of , FDA export datePage updated Source: openFDA, public domain