The following data is part of a premarket notification filed by Pt. Medisafe Technologies with the FDA for Powderfree Colored Latex Examination Gloves (pink, Blue, Green, And White) With Protein Content Labeling Claim (50 Micr0.
| Device ID | K010483 |
| 510k Number | K010483 |
| Device Name: | POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WITH PROTEIN CONTENT LABELING CLAIM (50 MICR0 |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. MEDISAFE TECHNOLOGIES JL. LET-JEN. S. PARMAN NO. 23/235 Medan, ID 20153 |
| Contact | Anil Taneja |
| Correspondent | Anil Taneja PT. MEDISAFE TECHNOLOGIES JL. LET-JEN. S. PARMAN NO. 23/235 Medan, ID 20153 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-20 |
| Decision Date | 2001-05-03 |