The following data is part of a premarket notification filed by Pt. Eka Wira Asia with the FDA for Nitrile Examination Gloves- Pre-powdered (small, Medium & Large).
| Device ID | K980729 |
| 510k Number | K980729 |
| Device Name: | NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE) |
| Classification | Polymer Patient Examination Glove |
| Applicant | PT. EKA WIRA ASIA 12110 E. SLAUSON AVE., SUITE 3 Santa Fe Springs, CA 90670 |
| Contact | Emmy Tjoeng |
| Correspondent | Emmy Tjoeng PT. EKA WIRA ASIA 12110 E. SLAUSON AVE., SUITE 3 Santa Fe Springs, CA 90670 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-25 |
| Decision Date | 1998-04-02 |
| Summary: | summary |