The following data is part of a premarket notification filed by Harry Panzer Intl. Corp. with the FDA for Gold Class, Grandtex, Latex Examination Gloves.
| Device ID | K891648 |
| 510k Number | K891648 |
| Device Name: | GOLD CLASS, GRANDTEX, LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | HARRY PANZER INTL. CORP. 275, HALSTEAD AVE. Harrison, NY 10528 |
| Contact | Harry Panzer |
| Correspondent | Harry Panzer HARRY PANZER INTL. CORP. 275, HALSTEAD AVE. Harrison, NY 10528 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-17 |
| Decision Date | 1989-04-07 |