The following data is part of a premarket notification filed by Rubberex Alliance Products Sdn Bhd with the FDA for Non-sterile Powder Free Nitrile Examination Gloves (tested For Use With Chemotherapy Drugs).
| Device ID | K221350 |
| 510k Number | K221350 |
| Device Name: | Non-Sterile Powder Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Rubberex Alliance Products Sdn Bhd Lot 138201 Off 3/4 Mile, Jalan Bercham, Kawasan Perindustrian Bercham Ipoh, MY 31400 |
| Contact | Sabri Bin Abdul Hamid |
| Correspondent | Kewin Tham Mdi Consultants, Inc. 55 Northern Blvd, Suite 200 Great Neck, NY 11021 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | OPJ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-10 |
| Decision Date | 2022-08-05 |