The following data is part of a premarket notification filed by Ampri Rubberware Industries Sdn Bhd with the FDA for Absogel Chemotheraphy Gloves.
Device ID | K990677 |
510k Number | K990677 |
Device Name: | ABSOGEL CHEMOTHERAPHY GLOVES |
Classification | Patient Examination Glove, Specialty |
Applicant | AMPRI RUBBERWARE INDUSTRIES SDN BHD LOT B5 & B6, PHASE II, KAWASAN PERINDUSTRIAN MIEL Batang Kali, Selangor, MY 44300 |
Contact | Li Kim Phng |
Correspondent | Li Kim Phng AMPRI RUBBERWARE INDUSTRIES SDN BHD LOT B5 & B6, PHASE II, KAWASAN PERINDUSTRIAN MIEL Batang Kali, Selangor, MY 44300 |
Product Code | LZC |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-02 |
Decision Date | 1999-11-01 |