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 |