The following data is part of a premarket notification filed by Arista Latindo Industrial, Ltd. P.t. with the FDA for Blue Latex Examination Gloves, Powder Free.
| Device ID | K013320 |
| 510k Number | K013320 |
| Device Name: | BLUE LATEX EXAMINATION GLOVES, POWDER FREE |
| Classification | Latex Patient Examination Glove |
| Applicant | ARISTA LATINDO INDUSTRIAL, LTD. P.T. 128 JALAN KYAI HAJI MUHAMMAD MANSYUR Jakarta Barat, ID 11210 |
| Contact | Linga Sumarta |
| Correspondent | Linga Sumarta ARISTA LATINDO INDUSTRIAL, LTD. P.T. 128 JALAN KYAI HAJI MUHAMMAD MANSYUR Jakarta Barat, ID 11210 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-05 |
| Decision Date | 2001-12-19 |