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 Purple (pink/blue) Colored Powdered Latex Exam With Protein Labeling Claim [.
| Device ID | K000217 |
| 510k Number | K000217 |
| Device Name: | ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [ |
| Classification | Latex Patient Examination Glove |
| Applicant | SHIELD GLOVES MANUFACTURER (M) SDN BHD 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 -9550 |
| Contact | Janna P Tucker |
| Correspondent | Janna P Tucker SHIELD GLOVES MANUFACTURER (M) SDN BHD 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 -9550 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-24 |
| Decision Date | 2000-02-18 |