The following data is part of a premarket notification filed by American Healthcare Products (m) Sdn Bhd with the FDA for Uniseal Gloves Low Protein Powdered.
Device ID | K981979 |
510k Number | K981979 |
Device Name: | UNISEAL GLOVES LOW PROTEIN POWDERED |
Classification | Latex Patient Examination Glove |
Applicant | AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD PT 7521 TAMAN SEMARAK II LIGHT INDUSTRIAL PARK Nilai, Negeri Sembilan 71800, MY 71800 |
Contact | Tarani Devi |
Correspondent | Tarani Devi AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD PT 7521 TAMAN SEMARAK II LIGHT INDUSTRIAL PARK Nilai, Negeri Sembilan 71800, MY 71800 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-06-05 |
Decision Date | 1998-11-30 |