The following data is part of a premarket notification filed by Hl Rubber Industries Sdn Bhd with the FDA for Powder Free Nitrile Examination Gloves, Blue, Tested For Use With Chemotherapy Drugs.
| Device ID | K220545 |
| 510k Number | K220545 |
| Device Name: | Powder Free Nitrile Examination Gloves, Blue, Tested For Use With Chemotherapy Drugs |
| Classification | Patient Examination Glove, Specialty |
| Applicant | HL Rubber Industries Sdn Bhd Lot 10, Kawasan Perindustrian Dioh, Kuala Pilah, MY 72000 |
| Contact | Noorzaliza Ahmad |
| Correspondent | Noorzaliza Ahmad HL Rubber Industries Sdn Bhd Lot 10, Kawasan Perindustrian Dioh, Kuala Pilah, MY 72000 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-25 |
| Decision Date | 2022-05-26 |