The following data is part of a premarket notification filed by Glove Source, Inc. with the FDA for Blue Nitrile Examination Gloves - Powder Free.
| Device ID | K994064 |
| 510k Number | K994064 |
| Device Name: | BLUE NITRILE EXAMINATION GLOVES - POWDER FREE |
| Classification | Polymer Patient Examination Glove |
| Applicant | GLOVE SOURCE, INC. 889 SOUTH AZUSA AVE. City Of Industry, CA 91748 |
| Contact | Emmy Tjoeng |
| Correspondent | Emmy Tjoeng GLOVE SOURCE, INC. 889 SOUTH AZUSA AVE. City Of Industry, CA 91748 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-01 |
| Decision Date | 2000-01-28 |
| Summary: | summary |