The following data is part of a premarket notification filed by Premier Pathway Sdn. Bhd. with the FDA for Powdered Latex Exam Gloves, Protein Labeling (150 Microgram Or Less).
| Device ID | K001327 |
| 510k Number | K001327 |
| Device Name: | POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | PREMIER PATHWAY SDN. BHD. 198 AVENUE DE LA D'EMERALD Sparks, NV 89430 -9550 |
| Contact | Janna P Tucker |
| Correspondent | Janna P Tucker PREMIER PATHWAY SDN. BHD. 198 AVENUE DE LA D'EMERALD Sparks, NV 89430 -9550 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-26 |
| Decision Date | 2000-05-23 |