The following data is part of a premarket notification filed by Skil-care Corp. with the FDA for Padded Mitts/padded-plus Mitts/finger Separator Padded Mitts/rigid Palm Padded Mitts.
| Device ID | K963458 |
| 510k Number | K963458 |
| Device Name: | PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS |
| Classification | Restraint, Protective |
| Applicant | SKIL-CARE CORP. 167 SAW MILL RIVER RD. Yonkers, NY 10701 |
| Contact | Arnold Silverman |
| Correspondent | Arnold Silverman SKIL-CARE CORP. 167 SAW MILL RIVER RD. Yonkers, NY 10701 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-03 |
| Decision Date | 1996-10-18 |
| Summary: | summary |