The following data is part of a premarket notification filed by Pastel Glove Sdn Bhd with the FDA for Powder Free Nitrile Examination Glove.
| Device ID | K210369 |
| 510k Number | K210369 |
| Device Name: | Powder Free Nitrile Examination Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Pastel Glove Sdn Bhd PT285724, Jalan Pusing, Taman Perindustrian Perabot Negeri Park Pusing, MY 31550 |
| Contact | Siou Wei Law |
| Correspondent | Terence Lim Pastel Glove Sdn Bhd PT285724, Jalan Pusing, Taman Perindustrian Perabot Negeri Park Pusing, MY 31550 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-08 |
| Decision Date | 2021-05-13 |