The following data is part of a premarket notification filed by Platinum Glove Industries Sdn Bhd with the FDA for Powder Free Blue Nitrile Examination Gloves - Tested For Use With Chemotherapy Drugs.
| Device ID | K182089 |
| 510k Number | K182089 |
| Device Name: | Powder Free Blue Nitrile Examination Gloves - Tested For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| Applicant | Platinum Glove Industries Sdn Bhd Lot 6491-A, Batu 5 3/4, Sementa, Jalan Kapar Selangor Darul Ehsan, MY 42100 |
| Contact | Foo Khon Pu |
| Correspondent | Poppy Farah Rosa Platinum Glove Industries Sdn. Bhd. Lot 6491-A, Batu 5 3/4, Sementa, Jalan Kapar Selangor Darul Ehsan, MY 42100 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-02 |
| Decision Date | 2019-07-30 |