The following data is part of a premarket notification filed by Shield Gloves Manufacturer (m) Sdn Bhd with the FDA for Royal Shield Non-sterile Latex Exam Gloves-strawberry.
| Device ID | K943044 |
| 510k Number | K943044 |
| Device Name: | ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-STRAWBERRY |
| 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 | 1994-06-27 |
| Decision Date | 1994-09-26 |