The following data is part of a premarket notification filed by Pt. Medisafe Technologies with the FDA for Modification To Powderfree Colored And Flavored Chloroprene Patient Examination Gloves.
| Device ID | K040607 |
| 510k Number | K040607 |
| Device Name: | MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | PT. MEDISAFE TECHNOLOGIES JL. KAPT. PATTIMURA NO. 23 Medan, North Sumatra, ID 20153 |
| Contact | Anil Taneja |
| Correspondent | Anil Taneja PT. MEDISAFE TECHNOLOGIES JL. KAPT. PATTIMURA NO. 23 Medan, North Sumatra, ID 20153 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-08 |
| Decision Date | 2004-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00686864059561 | K040607 | 000 |
| 20686864056083 | K040607 | 000 |
| 20686864056076 | K040607 | 000 |
| 20686864056069 | K040607 | 000 |
| 20686864056052 | K040607 | 000 |
| 20686864056045 | K040607 | 000 |