The following data is part of a premarket notification filed by Shield Gloves Manufacturer (m) Sdn Bhd with the FDA for Smart Shield Non-sterile Powder-free, Blue Nitrile Examination Gloves With Bubblegum Scent.
| Device ID | K991744 |
| 510k Number | K991744 |
| Device Name: | SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT |
| Classification | Polymer Patient Examination Glove |
| Applicant | SHIELD GLOVES MANUFACTURER (M) SDN BHD P.O. BOX 4341 Crofton, MD 21114 |
| Contact | E. J. Smith |
| Correspondent | E. J. Smith SHIELD GLOVES MANUFACTURER (M) SDN BHD P.O. BOX 4341 Crofton, MD 21114 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-21 |
| Decision Date | 1999-06-23 |
| Summary: | summary |