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 |