The following data is part of a premarket notification filed by Shield Gloves Manufacturer (m) Sdn Bhd with the FDA for Royalshield Non-sterile Powder-free.
| Device ID | K945031 |
| 510k Number | K945031 |
| Device Name: | ROYALSHIELD NON-STERILE POWDER-FREE |
| Classification | Latex Patient Examination Glove |
| Applicant | SHIELD GLOVES MANUFACTURER (M) SDN BHD 89 2ND FLOOR JALAN SS 15/4C, SUBANG JAYA Selangor Darul Ehsan, MY 47500 |
| Contact | Katherine Ooi |
| Correspondent | Katherine Ooi SHIELD GLOVES MANUFACTURER (M) SDN BHD 89 2ND FLOOR JALAN SS 15/4C, SUBANG JAYA Selangor Darul Ehsan, MY 47500 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-13 |
| Decision Date | 1995-01-11 |