The following data is part of a premarket notification filed by Arista Latindo Industrial, Ltd. P.t. with the FDA for Laxtex Examination Gloves, Powdered Contains 180 Mcgm Or Less Of Total Water Extractable Protein Per Gram.
| Device ID | K022987 |
| 510k Number | K022987 |
| Device Name: | LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM |
| Classification | Latex Patient Examination Glove |
| Applicant | ARISTA LATINDO INDUSTRIAL, LTD. P.T. JL: K.H.MOH MANSYUR NO. 128 Jakarta, ID 11210 |
| Contact | Linga Sumarta |
| Correspondent | Linga Sumarta ARISTA LATINDO INDUSTRIAL, LTD. P.T. JL: K.H.MOH MANSYUR NO. 128 Jakarta, 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 | 2002-09-09 |
| Decision Date | 2002-10-21 |