Spi Gloves Sdn. Bhd.
Ipoh 30450, MY
Spi Gloves Sdn. Bhd. appears in FDA device records in Ipoh 30450, MY. FDA records list 7 510(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
- 7
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 7 510(k) clearances for Spi Gloves Sdn. Bhd. in 2005.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 7 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K050526 | POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR | LYY | Substantially Equivalent | |
| K050528 | POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK) | LZA | Substantially Equivalent | |
| K050532 | CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA | LYY | Substantially Equivalent | |
| K050531 | POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE) | LZA | Substantially Equivalent | |
| K050527 | POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL | LYY | Substantially Equivalent | |
| K050530 | POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN) | LZA | Substantially Equivalent | |
| K050529 | POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER | 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