The following data is part of a premarket notification filed by Hong Seng Gloves Sdn Bhd with the FDA for Powder Free Nitrile Examination Glove- Blue, Non-sterile.
| Device ID | K212804 |
| 510k Number | K212804 |
| Device Name: | Powder Free Nitrile Examination Glove- Blue, Non-sterile |
| Classification | Polymer Patient Examination Glove |
| Applicant | Hong Seng Gloves Sdn Bhd LOT 97, Jalan 10, Kawasan Perusahaan Bakar Arang Sungai Petani, MY 08000 |
| Contact | Ho Chia Yao |
| Correspondent | Michael Van Der Woude Emergo Global Representative LLC, 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-02 |
| Decision Date | 2021-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09551012690051 | K212804 | 000 |
| 09551012690044 | K212804 | 000 |
| 09551012690037 | K212804 | 000 |
| 09551012690020 | K212804 | 000 |
| 09551012690013 | K212804 | 000 |
| 09551012690006 | K212804 | 000 |