The following data is part of a premarket notification filed by Pt. Eka Wira Asia with the FDA for Latex Examination Gloves, Powder Free.
| Device ID | K941056 |
| 510k Number | K941056 |
| Device Name: | LATEX EXAMINATION GLOVES, POWDER FREE |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. EKA WIRA ASIA JL. HAJI ZAINAI ARIFIN 128 B-C Medan 20112 - Indonesia, ID |
| Contact | Hansen Laurence |
| Correspondent | Hansen Laurence PT. EKA WIRA ASIA JL. HAJI ZAINAI ARIFIN 128 B-C Medan 20112 - Indonesia, ID |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-03 |
| Decision Date | 1994-04-29 |