The following data is part of a premarket notification filed by Safeskin Corp. with the FDA for Nitrile Rubber Powder-free Examination Glove.
| Device ID | K932404 |
| 510k Number | K932404 |
| Device Name: | NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE |
| Classification | Patient Examination Glove |
| Applicant | SAFESKIN CORP. CROCKER CENTER 5100 TOWN CENTER CIRCLE Boca Raton, FL 33486 |
| Contact | Jeanne D Braverman |
| Correspondent | Jeanne D Braverman SAFESKIN CORP. CROCKER CENTER 5100 TOWN CENTER CIRCLE Boca Raton, FL 33486 |
| Product Code | FMC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-13 |
| Decision Date | 1994-05-18 |