The following data is part of a premarket notification filed by Best Putra Gloves Sdn Bhd with the FDA for Powdered, Natural Color, Latex Examination Glove Model: Mep1.
Device ID | K101106 |
510k Number | K101106 |
Device Name: | POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1 |
Classification | Latex Patient Examination Glove |
Applicant | BEST PUTRA GLOVES SDN BHD MOHD TAIB, KAWASAN PERINDUSTRIAN Sg Choh Rawang, Selangor, MY 48000 |
Contact | Effendi Tenang |
Correspondent | Effendi Tenang BEST PUTRA GLOVES SDN BHD MOHD TAIB, KAWASAN PERINDUSTRIAN Sg Choh Rawang, Selangor, MY 48000 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-04-20 |
Decision Date | 2010-11-10 |
Summary: | summary |