The following data is part of a premarket notification filed by Ampri Rubberware Industries Sdn Bhd with the FDA for Powder-free Latex Examination Glove With Protein Labeling Claim (contains 50 Micrograms Or Less Of Total Water Extracta.
| Device ID | K990812 |
| 510k Number | K990812 |
| Device Name: | POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTA |
| Classification | Latex Patient Examination Glove |
| Applicant | AMPRI RUBBERWARE INDUSTRIES SDN BHD LOT B5 & B6, PHASE II, KAWASAN PERINDUSTRIAN MIEL Batang Kali, Selangor, MY 44300 |
| Contact | Pack Loon Tang |
| Correspondent | Pack Loon Tang AMPRI RUBBERWARE INDUSTRIES SDN BHD LOT B5 & B6, PHASE II, KAWASAN PERINDUSTRIAN MIEL Batang Kali, Selangor, MY 44300 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-11 |
| Decision Date | 1999-05-04 |