The following data is part of a premarket notification filed by Pt. Smart Glove Indonesia with the FDA for Powder Free Latex Examination Gloves With Protein Labeling Claim Less Than 50 Microgram Or Less Of Total Water Extractab.
| Device ID | K030112 |
| 510k Number | K030112 |
| Device Name: | POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTAB |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. SMART GLOVE INDONESIA KAWASAN INDUSTRI MEDAN STAR J1 RAYA MEDAN-LUBUK PAKAM KM.19 Tg Morawa-deli Serdang Utara, ID 20362 |
| Contact | Foo Khon Pu |
| Correspondent | Foo Khon Pu PT. SMART GLOVE INDONESIA KAWASAN INDUSTRI MEDAN STAR J1 RAYA MEDAN-LUBUK PAKAM KM.19 Tg Morawa-deli Serdang Utara, ID 20362 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-13 |
| Decision Date | 2003-02-27 |