The following data is part of a premarket notification filed by Nam Viet Glove Joint Stock Company with the FDA for Powder Free Nitrile Examination Gloves (blue).
| Device ID | K162113 |
| 510k Number | K162113 |
| Device Name: | Powder Free Nitrile Examination Gloves (Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | NAM VIET GLOVE JOINT STOCK COMPANY HAMLET 7, PHUOC BINH COMMUNE LONG THANH DISTRICT Ho Chi Minh, VN 815300 |
| Contact | Ooi Loon Seng |
| Correspondent | Ooi Loon Seng NAM VIET GLOVE JOINT STOCK COMPANY HAMLET 7, PHUOC BINH COMMUNE LONG THANH DISTRICT Ho Chi Minh, VN 815300 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-29 |
| Decision Date | 2016-11-07 |
| Summary: | summary |