The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Powdered Latex Examination Gloves With Protein Content Labeling Claim Of 200 Micrograms Or Less.
Device ID | K993760 |
510k Number | K993760 |
Device Name: | POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS |
Classification | Latex Patient Examination Glove |
Applicant | HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE Kuala Lumpur, MY 52100 |
Contact | Kuan Kam Hon |
Correspondent | Kuan Kam Hon HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE Kuala Lumpur, MY 52100 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-08 |
Decision Date | 2000-05-15 |