Shield Gloves Manufacturer (M) Sdn Bhd
Sparks, NV, US
Shield Gloves Manufacturer (M) Sdn Bhd appears in FDA device records in Sparks, NV. FDA records list 18 510(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
- 18
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 18 510(k) clearances for Shield Gloves Manufacturer (M) Sdn Bhd between 1994 and 2001. The busiest year on record is 1999, with 7. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 4 |
| 1995 | 3 |
| 1997 | 1 |
| 1999 | 7 |
| 2000 | 2 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K011613 | POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE | LZA | Substantially Equivalent | |
| K000217 | ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W | LYY | Substantially Equivalent | |
| K000156 | SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K992419 | ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR | LYY | Substantially Equivalent | |
| K992418 | ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH AND WITHOUT STRAWBERRY SCENT AND WITH PROTEI | LYY | Substantially Equivalent | |
| K992417 | ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR | LYY | Substantially Equivalent | |
| K991746 | ROYAL SHIELD POWDER-FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR | LYY | Substantially Equivalent | |
| K991745 | ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM | LYY | Substantially Equivalent | |
| K991744 | SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT | LZA | Substantially Equivalent | |
| K991743 | ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O | LYY | Substantially Equivalent | |
| K972757 | ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | |
| K953496 | ROYAL SHIELD NON-STERILE POWDER-FREE HYPOALLERGENIC LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K952589 | ROYAL SHIELD PINK & BLUE COLORED NON-STERILE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K945031 | ROYALSHIELD NON-STERILE POWDER-FREE | LYY | Substantially Equivalent | |
| K943807 | ROYAL SHIELD PINK COLORED NON-STERILE LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K943044 | ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-STRAWBERRY | LYY | Substantially Equivalent | |
| K943043 | ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-BUBBLE GUM | LYY | Substantially Equivalent | |
| K942940 | ROYAL SHIELD POWDER-FREE LATEX EXAMANATION 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