The following data is part of a premarket notification filed by Kossan Latex Industries (m) Sdn. Bhd. with the FDA for Polymer Coated, Powder-free Latex Examination Glove Contains 50 Micrograms Or Less Of Total Water Extractable Protein Pe.
Device ID | K001190 |
510k Number | K001190 |
Device Name: | POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE |
Classification | Latex Patient Examination Glove |
Applicant | KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LOT 16632, 5-1/4 MILES, JALAN MERU Kelang, Selangor, MY 41050 |
Contact | Lim Kwan Hwa |
Correspondent | Lim Kwan Hwa KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LOT 16632, 5-1/4 MILES, JALAN MERU Kelang, Selangor, MY 41050 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-04-12 |
Decision Date | 2000-05-23 |