The following data is part of a premarket notification filed by Hti Trading Group with the FDA for Baldur Vinyl Powdered Gloves.
| Device ID | K963441 |
| 510k Number | K963441 |
| Device Name: | BALDUR VINYL POWDERED GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | HTI TRADING GROUP 3423 INVESTMENT BLVD. SUITE 12 Hayward, CA 94545 |
| Contact | David Hu |
| Correspondent | David Hu HTI TRADING GROUP 3423 INVESTMENT BLVD. SUITE 12 Hayward, CA 94545 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-30 |
| Decision Date | 1997-02-14 |