The following data is part of a premarket notification filed by Watchtower Ppe Supplies Inc. with the FDA for Nitrile Examination Gloves.
| Device ID | K212929 |
| 510k Number | K212929 |
| Device Name: | Nitrile Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Watchtower PPE Supplies Inc. 600 W John Street, Ste 140B Hicksville, NY 11801 |
| Contact | Riva Zheng |
| Correspondent | Rafi Wong Pacific Fortune Management Inc. 2350 Mission College Blvd, Ste 475 Santa Clara, CA 95054 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-14 |
| Decision Date | 2022-04-09 |