The following data is part of a premarket notification filed by Arista Latindo Industrial, Ltd. P.t. with the FDA for Latex Examination Gloves, Powder Free With Protein Labeling Claim (50 Mcg Or Less).
| Device ID | K991686 |
| 510k Number | K991686 |
| Device Name: | LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS) |
| 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 | 1999-05-17 |
| Decision Date | 1999-06-11 |