The following data is part of a premarket notification filed by Maxxim Medical with the FDA for Polyurethane Powder Free Dental Examination Glove, Polyurethane Powder Free Medical Examination Glove.
| Device ID | K991615 |
| 510k Number | K991615 |
| Device Name: | POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE |
| Classification | Polymer Patient Examination Glove |
| Applicant | MAXXIM MEDICAL 477 COMMERCE BLVD. Oldsmar, FL 34677 |
| Contact | Joyce Moody |
| Correspondent | Joyce Moody MAXXIM MEDICAL 477 COMMERCE BLVD. Oldsmar, FL 34677 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-10 |
| Decision Date | 1999-07-30 |
| Summary: | summary |