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 Powder-free Hypoallergenic Latex Examination Gloves.
| Device ID | K953496 |
| 510k Number | K953496 |
| Device Name: | ROYAL SHIELD NON-STERILE POWDER-FREE HYPOALLERGENIC LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | SHIELD GLOVES MANUFACTURER (M) SDN BHD 89, 2ND FL., JALAN SS, 15/4-C, SUBANG JAYA Selangor, MY 47500 |
| Contact | Ong Lay Mau |
| Correspondent | Ong Lay Mau SHIELD GLOVES MANUFACTURER (M) SDN BHD 89, 2ND FL., JALAN SS, 15/4-C, SUBANG JAYA Selangor, 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 | 1995-07-26 |
| Decision Date | 1995-09-08 |