The following data is part of a premarket notification filed by Maxter Glove Manufacturing Sdn Bhd with the FDA for Non-sterile Powder Free Blue Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs.
Device ID | K172864 |
510k Number | K172864 |
Device Name: | Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs |
Classification | Patient Examination Glove, Specialty |
Applicant | Maxter Glove Manufacturing Sdn Bhd Lot 6070, Jalan Haji Abdul Manah 6th Miles Off Jalan Meru Klang, MY 41050 |
Contact | Yap Peak Geeh |
Correspondent | Yap Peak Geeh Maxter Glove Manufacturing Sdn Bhd Lot 6070, Jalan Haji Abdul Manah 6th Miles Off Jalan Meru Klang, MY 41050 |
Product Code | LZC |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-20 |
Decision Date | 2018-05-02 |
Summary: | summary |